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Effects of dexamethasone on quality of recovery following vaginal surgery: a randomized trial Rachel N. Pauls, MD; Catrina C. Crisp, MD, MSc; Susan H. Oakley, MD; Lauren B. Westermann, DO; Donna Mazloomdoost, MD; Steven D. Kleeman, MD; Vivian Ghodsi, RN; Maria Victoria Estanol, MD OBJECTIVE: Dexamethasone is a corticosteroid with minimal side

effects that may improve quality of recovery. We sought to evaluate standard use of this medication prior to vaginal reconstructive surgery. STUDY DESIGN: This was a double-blind, randomized, placebo-

controlled trial of women undergoing vaginal reconstructive surgery for pelvic organ prolapse. Patients scheduled for an intraperitoneal vaginal vault suspension, with general anesthesia and an overnight stay, were enrolled. The intervention arm received dexamethasone 60 minutes prior to surgery, and controls received placebo. Postoperative pain medications, antiemetics, and voiding trials were standardized. Our primary outcome was the difference in Quality of Recovery (QoR-40) scores on postoperative day 1. Secondary measures included Postoperative Nausea and Vomiting Intensity scores, and visual analog scales for nausea/vomiting, and pain. Our power calculation demonstrated 31 subjects in each group would be necessary to document difference in QoR-40 scores; to allow for attrition, a goal of 74 subjects was set. RESULTS: Seventy-four women were enrolled and randomized.

Two withdrew, 9 were excluded, and 63 were analyzed (36 placebo, 27 dexamethasone). The mean age was 63 years. No significant differences were noted among demographics other than American Society for Anesthesiologists class; there were greater numbers of

dexamethasone subjects that were class 3 (5 vs 11; P ¼ .030). Postoperatively, more patients in the placebo group required promethazine as a rescue antiemetic for control of their nausea/vomiting (11 vs 2; P ¼ .029). Placebo subjects also failed their voiding trials more frequently, which remained following a logistic regression controlling for suburethral sling (30 vs 15; P ¼ .037). Regarding the QoR40 following surgery, the emotional state domain declined less in dexamethasone patients (e14.3, interquartile range [IQR], 16.8 vs e4.6, IQR, 20.1; P ¼ .042), indicating better symptoms. Whereas pain scales were similar, the visual analog scales for nausea/vomiting was lower in dexamethasone subjects (0.7; IQR, 4.1 vs 0.4; IQR, 1.4; P ¼ .042). Postoperative Nausea and Vomiting Intensity scores were not significantly different; nevertheless, twice as many placebo subjects had severe range symptoms (4 vs 2; P ¼ .47). No adverse effects from the dexamethasone were noted. CONCLUSION: Use of dexamethasone prior to vaginal reconstructive surgery was associated with less nausea/vomiting and need for antiemetics as well as greater success with voiding trials. Furthermore, quality of recovery was enhanced, suggesting use of dexamethasone should be considered for these patients.

Key words: dexamethasone, nausea, postoperative, prolapse, quality of recovery, vaginal surgery

Cite this article as: Pauls RN, Crisp CC, Oakley SH, et al. Effects of dexamethasone on quality of recovery following vaginal surgery: a randomized trial. Am J Obstet Gynecol 2015;213:718.e1-7.

R

educing postoperative complications and improving quality outcomes are important goals for surgeons and health care systems. Quality of recovery (QOR) is a quantification of various postoperative dimensions such as

physical and emotional well-being.1 Poor QOR has been associated with longer hospital stays, delayed convalescence,2 and lower patient satisfaction.3,4 Two of patients’ most feared postoperative complications that have an impact on QOR

From the Division of Urogynecology, Department of Obstetrics and Gynecology (Drs Pauls, Crisp, Westermann, Mazloomdoost, and Kleeman); St. Elizabeth Physicians, Division of Female Pelvic Medicine and Reconstructive Surgery, Fort Thomas, KY (Dr Oakley); William Beaumont Hospital/ Oakland University School of Medicine, Royal Oak, MI (Dr Estanol); and Hatton Research Institute (Ms Ghodsi), TriHealth Good Samaritan Hospital, Cincinnati, OH. Received Dec. 19, 2014; revised April 16, 2015; accepted May 28, 2015. The authors report no conflict of interest. Presented in oral format at the 41st annual scientific meeting of the Society of Gynecologic Surgeons, Orlando, FL, March 22-25, 2015. Corresponding author: Rachel N. Pauls, MD. [email protected] 0002-9378/$36.00  ª 2015 Elsevier Inc. All rights reserved.  http://dx.doi.org/10.1016/j.ajog.2015.05.061

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are uncontrolled pain and postoperative nausea and vomiting (PONV).5 Strategies to reduce these consequences can improve outcomes and reduce morbidity. Dexamethasone is a potent corticosteroid, which has been used in combination with other antiemetics to augment their effect.6,7 The mechanism of action is not completely understood, but it appears to act synergistically with serotonin receptor antagonists to reduce nausea while also providing analgesic benefits.5 In fact, the Enhanced Recovery After Surgery program5 recommends that patients with a history of PONV receive dexamethasone during anesthesia to reduce this complication.5 Because of the robust impact of dexamethasone, it has been suggested that all patients undergoing surgery should

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ajog.org be considered candidates for this treatment. Indeed, dexamethasone has been evaluated in conjunction with both regional and general anesthesia prior to cesarean delivery,8 laparoscopic cholecystectomy, and ambulatory gynecology surgery,9-12 with improvements in PONV, opioid consumption,10 and QOR. The administration of dexamethasone is inexpensive, with minimal side effects and risks.11 In conjunction with other medications, dexamethasone may be part of a multimodal treatment plan that could enhance symptom control.13 Vaginal reconstructive surgery for pelvic organ prolapse is a common and minimally invasive procedure, with most patients being discharged on postoperative day one (POD#1). However, poor QOR may delay advancing care. Moreover, female patients have been shown to be at risk for inferior QOR,2,4 rendering it important to seek treatment modalities that benefit them. Dexamethasone has the potential to be efficacious in this regard, yet such application has not been investigated. Therefore, the purpose of this

randomized controlled trial was to evaluate whether standard administration of dexamethasone prior to general anesthesia induction would result in improved patient QOR following vaginal reconstructive surgery as compared with placebo. Secondary outcomes were to document symptoms of PONV and pain control.

M ATERIALS

AND

M ETHODS

This was an institutional review boardeapproved, randomized, doubleblind, placebo-controlled trial. All subjects were patients of a tertiary care referral-based urogynecology practice and planning surgery at 1 of the 2 hospitals in the health care system, TriHealth Inc (Cincinnati, OH). Study enrollment was between January 2013 and June 2014. The study was registered with the National Clinical Trials Registry (NCT no. 02073734). Subjects were eligible if they consented to major vaginal reconstructive surgery for symptomatic pelvic organ prolapse of stage 2 or greater14 involving general anesthesia and an overnight

FIGURE

Consort diagram

Pauls. Recovery following vaginal surgery using dexamethasone. Am J Obstet Gynecol 2015.

stay. Surgery was to include an anterior and posterior colporrhaphy with an intraperitoneal vaginal vault suspension to the uterosacral ligaments. Other concomitant procedures such as hysterectomy and antiincontinence surgery could be performed. Subjects were excluded if their surgical procedure involved the removal of transvaginal mesh, placement of transvaginal mesh, robotic or abdominal surgical treatment, anal sphincteroplasty, or anal fistula repair. Other criteria for exclusion included an inability to perform an intraperitoneal vaginal vault suspension, daily use of steroids or antiemetics in the month before surgery, history of PONV (which would allocate them to receive dexamethasone per our institutional standard of care), planned regional anesthesia, chronic pain requiring daily opioid treatment, history of allergy to the study medication, severe renal or liver disease, uncontrolled diabetes, pregnancy, non-English speaking or inability to complete the questionnaires, and evidence of systemic fungal or other infections. Patients were approached and enrolled at the time of surgical consent or in the preoperative area before surgery. Our randomization schedule was conducted using a computer-generated table into 2 groups. All subjects were assigned a number and the hospital pharmacy was provided a confidential table to allocate each patient. On the day of surgery, the study number was communicated to the pharmacy, and only the pharmacist was aware of the group allocation. The patient, physicians, anesthesia personnel, nursing, data collection staff, and statistician were all blinded. The intervention group received 8 mg dexamethasone intravenously 60 minutes prior to surgery, whereas the placebo group received an identical syringe with normal saline solution. The dexamethasone is concentrated at a dose of 4 mg/mL, and thus, all subjects received 2 mL of solution containing either study drug or saline. The drugs were provided before the patient’s induction of anesthesia in a similar design to prior research.10 The purpose of this timing was to optimize the impact of the

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SGS Papers dexamethasone on the stress response of the surgical start. The peak effect of the medication is within 45 minutes to 1 hour.10 All surgeries were performed by board-certified surgeons in female pelvic medicine and reconstructive surgery using a similar technique. As part of the academic institutional affiliation, fellows also participated in portions of the surgery with direct supervision. Lidocaine with epinephrine (1%) was injected into the vaginal mucosa for vasoconstriction and hydrodissection. After the peritoneal cavity was entered, packing was placed in the pelvis using moist laparotomy sponges to aid in visualization. A high uterosacral ligament suspension was performed in a previously described manner using 2 delayed-absorbable sutures through each uterosacral ligament, at or above the ischial spines bilaterally, and brought through the vaginal cuff.15 All patients also underwent an internal McCall’s culdoplasty (permanent suture reefed across the posterior cul-de-sac peritoneum incorporating the uterosacral ligaments bilaterally and tied intraperitoneally). Baseline data included demographics, medical history, and physical examination findings. Surgical information recorded included anesthesia medications, surgery duration, estimated blood loss, and all other intraoperative medications. Postoperative data were collected regarding postoperative pain medications, antiemetics, complications, nursing verbal pain scores from 0 to 10 (0 indicating no pain and 10 indicating maximum pain), and voiding trial results. Complications were recorded including postoperative fever (defined as temperature elevation greater than 100.4 F), blood transfusion, anemia (as diagnosed by the treating physician, or a hemoglobin level <10 g/dL), neuropathy, and ileus. All patients received a standardized regimen for pain control: patientcontrolled analgesia (PCA), with intravenous (IV) hydromorphone for breakthrough pain as needed. IV ketorolac was available on request every 6 hours (30 mg for patients younger

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TABLE 1

Baseline characteristics of patients Characteristic

Placebo (n [ 36)

Dexamethasone (n [ 27)

Age, mean (SD), y

62.0 (9.6)

63.2 (8.3)

.61b

BMI, median (IQR)

26.8 (5.1)

28.4 (6.3)

.40c

2 (5.6)

0 (0.0)

.50

P valuea

Comorbiditiesd Motion sickness Depression

6 (16.7)

4 (14.8)

1.00

Irritable bowel syndrome

3 (8.3)

1 (3.7)

.63

Fibromyalgia

1 (2.8)

2 (7.4)

.57

Chronic pain syndrome

1 (2.8)

0 (0.0)

1.00

Diabetes

5 (13.9)

1 (3.7)

.23

Endometriosis

1 (2.8)

0 (0.0)

1.00

Hysterectomy

5 (13.9)

7 (25.9)

.23e

Hysterectomy with oophorectomy

3 (8.3)

4 (14.8)

.45

Prior prolapse repair

2 (5.6)

3 (11.1)

.64

Other abdominal surgery

8 (22.2)

10 (37.0)

.20e

31 (86.1)

23 (85.2)

1.00

5 (13.9)

4 (15.4)

1.00

Gravidity, median (IQR)

3.0 (2.0)

3.0 (2.0)

.87c

Parity, median (IQR)

3.0 (1.0)

2.0 (2.0)

.90c

Vaginal deliveries, median (IQR)

2.0 (1.0)

3.0 (2.0)

.42c

3 (8.3)

5 (19.2)

.26

12 (33.3)

11 (42.3)

.47e

0 (0.0)

1 (3.8)

.42

Surgical history

Gynecological history Postmenopausal Using hormone replacement therapy Obstetrical history

Social history Smoker Alcohol use Illicit drug use BMI, body mass index; IQR, interquartile range. a

P values are for the Fisher exact test unless otherwise noted; b Unpaired Student t test; c Mann-Whitney rank sum test; d Values are expressed as n (percentage) unless otherwise noted; e c2 test.

Pauls. Recovery following vaginal surgery using dexamethasone. Am J Obstet Gynecol 2015.

than 65 years and 15 mg for patients older than 65 years of age). All patients were transitioned to oral medications on POD#1 and were provided both oxycodone 5-10 mg/acetaminophen 325-650 mg every 4 hours and ibuprofen 600 mg every 6 hours as needed. A standardized antiemetic regimen instructed nursing to administer ondansetron 4 mg IV every 8 hours as first line, followed by metoclopramide 10 mg IV every 6-8 hours and promethazine

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25 mg IV every 4-6 hours for refractory PONV. The Quality of Recovery-40 (QoR40) is a validated scale with 5 domains.2,3,10 These measure physical comfort, emotional state, physical independence, psychological support, and pain. Each domain is scored to a maximum global score of 200. Higher scores indicate better QOR. QoR-40 scores have been found to be associated with both quality-of-life scales and

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TABLE 2

Perioperative data Variable

Placebo n [ 36

Dexamethasone n [ 27 P valuea

Type of surgeryb 27 (75.0)

16 (59.3)

.18c

Unilateral oophorectomy

0 (0.0)

1 (3.7)

.43

Bilateral oophorectomy

2 (5.6)

4 (14.8)

.39

Anterior repair

33 (91.7)

24 (88.9)

1.00

Posterior repair

33 (91.7)

27 (100.0)

.25

Suburethral sling procedure

16 (44.4)

6 (22.2)

.11

I

4 (11.4)

1 (4.0)

.55

II

26 (74.3)

13 (52.0)

Vaginal hysterectomy

Anesthesia data Anesthesia classd n/a

III

5 (14.3)

11 (44.0)

General

36 (100.0)

27 (100.0)

.03

Local lidocaine, mean (SD), mL

29.4 (9.7)

24.8 (12.3)

Inhalational

35 (97.2)

27 (100.0)

Fentanyl

36 (100.0)

27 (100.0)

— .10e,f

Anesthesia medications used, n (%), dosed

Morphine

1.00 —

2 (5.6)

2 (7.4)

1.00

Versed

30 (83.3)

22 (81.5)

1.00

Diprivan

35 (97.2)

26 (96.3)

1.00

Naloxone

0 (0.0)

1 (3.7)

.43

30 (83.3)

20 (74.1)

.37c

35 (97.2)

26 (96.3)

Metoclopramide

1 (2.8)

3 (11.1)

.31

Promethazine

5 (13.9)

4 (14.8)

1.00

Surgery duration, median (IQR), min

165.5 (56.0)

160.0 (50.0)

.32g

Estimated blood loss, median (IQR), mL

125.0 (50.0)

150.0 (100.0)

.31g

1977.8 (556.1) 1937.9 (741.3)

.81d

Glycopyrrolate Intraoperative antiemetics, n (%), dosed Ondansetron

1.00

Other intraoperative data

IVF, mean (SD), mL Postoperative pain medication used Total hydromorphone in PACU, median (IQR), mg

0.2 (1.0)

0.0 (1.0)

.22g

Total hydromorphone upon transfer to patient’s room, median (IQR), mg

0.7 (1.13)

0.4 (0.64)

.11g

Ketorolac, n (%), dosed

26 (74.30)

21 (77.80)

.44d

Total ketorolac, median (IQR), mg

30.0 (37.5)

30.0 (30.0)

.77g

Pauls. Recovery following vaginal surgery using dexamethasone. Am J Obstet Gynecol 2015.

(continued)

patient satisfaction indices4 as well as postoperative pain.1 Patients completed the QoR-40 index at baseline and in the morning of POD#1. On POD#1, subjects also completed a PONV Intensity Scale, and 2 visual analog scales (VAS) from 0 to 10 cm. One VAS queried about their level of pain, with 0 indicating no pain and 10 indicating severe pain. The other VAS asked about nausea and/or vomiting symptoms in a similar manner. VAS scales are widely used in behavioral science and previous studies report their usefulness and validity.16,17 The PONV scale is designed to measure clinically important nausea and vomiting. Four questions are asked, with a total score of greater than 50 indicating intense or clinically important symptoms.18,19 It has also been validated in gynecological patients.20 Our sample size calculation showed that a sample size of 31 subjects in each group would have 90% power to detect a mean difference of 22 points in the global QoR 40, SD 26 (n-Query Advisor; Statistical Solutions Ltd, Los Angeles, CA). This difference was noted in a prior study that evaluated preoperative dexamethasone after ambulatory gynecological surgery.10 To allow for patient attrition, a sample size of 74 subjects was set (6 additional subjects per group, or 20%). Statistical analysis was performed using SPSS (version 22; SPSS, Inc., Chicago, IL). Data were reported using c2 and Fisher exact tests. Nonparametric tests were applied when data did not meet assumptions of normality. To adjust for nonnormally distributed raw scoring data, the QoR-40 domain and global scores were analyzed by first computing the percent change between preoperative and postoperative scores and then comparing the mean or median percentage changes across study groups using either an unpaired Student t test or a Mann-Whitney rank sum test. Logistic regression was performed to control for suburethral sling procedure on outcome of voiding trials postoperatively. Statistical evaluation was performed by advisers in the Hatton Institute for Research and Education, a

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research arm for the affiliated institution, and all statisticians were blinded until data analysis was complete.

TABLE 2

R ESULTS

Variable

Seventy-nine women were approached to participate and 5 declined. Seventyfour were enrolled and randomized. Two withdrew, and 9 were excluded (1 did not have an intraperitoneal vaginal vault suspension, 1 canceled her surgery, 4 developed new medical problems and had to cancel surgery, 2 did not receive the study drug because of a pharmacy error, and 1 required hydrocortisone preoperatively). Thus, 63 were analyzed; 36 received placebo and 27 received dexamethasone (Figure). The mean age was 63 (SD 9) years and the mean body mass index was 29 (SD 5) kg/m2. No significant differences were noted in the demographics between the 2 groups at baseline other than American Society for Anesthesiologists (ASA) class. Dexamethasone subjects were more likely to be class 3 than class 2 when compared with placebo subjects, indicating higher morbidity in the dexamethasone cohort (P ¼ .030; odds ratio [OR], 4.40; 95% confidence interval [CI], 1.26e15.35). The type of anesthesia medications provided, amount of lidocaine injected (milliliters) for surgical dissection, surgical procedures, estimated blood loss, and surgical duration were the same. However, there was slightly more subjects who underwent a suburethral sling in the placebo group, which was not statistically significant (Table 1). Postoperative use of narcotics via PCA and other means were not different among the 2 groups. However, as a thirdline antiemetic, more required promethazine in the placebo arm than the dexamethasone (P ¼.029; OR, 5.28; 95% CI, 1.06e26.35). Although not statistically significant, subjects treated with placebo also received greater amounts of ondansetron and metoclopramide. Furthermore, subjects in the placebo group also failed their voiding trial on POD#1 more frequently and required discharge with a catheter (P ¼ .01) (Table 2). This difference remained following logistic regression controlling

Perioperative data (continued) Placebo n [ 36

Dexamethasone n [ 27 P valuea

PCA utilization of hydromorphone, mg POD 0, median (IQR)

1.4 (1.5)

1.4 (1.6)

.88g

POD 1, median (IQR)

1.0 (1.3)

1.0 (1.6)

.62g

Total, median (IQR)

2.4 (2.8)

2.6 (3.2)

.69g

Ondansetron, n (%), dosed

21 (58.3)

13 (50.0)

.52c

Ondanestron, median (IQR) doses/patient

1 (1.0)

1 (2.0)

.50g

5 (19.20)

.44c

Postop antiemetics used

Metoclopramide, n (%), dosed

10 (27.80)

Metoclopramide, median (IQR) doses/patient

1 (2.5)

2 (2.5)

.82g

Promethazine, n (%), dosed

11 (30.60)

2 (7.70)

.03h,c

Promethazine, median (IQR) doses/patient

1 (0.0)

1 (0.0)

.89g

0 (0.0)

1 (3.7)

.43

30 (85.7)

15 (57.7)

Postop complicationsi Anemia, n (%) Voiding trial results POD 1 Failed

.01h,c

IQR, interquartile range; IVF, in vitro fertilization; n/a, not available; PACU, postanesthesia care unit; PCA, patient-controlled analgesia; POD, postoperative day. a

P values are for the Fisher exact test unless otherwise noted; b Values are expressed as number of patients (percentage) unless otherwise noted; c c2 test; d P values are the result of logistic regression model using anesthesia class 2 as the reference level; e Unpaired Student t test; f Mean replacement used for missing data for 2 patients; g Mann-Whitney rank sum test; h P values are significant at the .05 level; i Other complications are not recorded in any subjects.

Pauls. Recovery following vaginal surgery using dexamethasone. Am J Obstet Gynecol 2015.

for sling procedure, supporting that patients receiving dexamethasone were less likely to fail their voiding trials (P ¼ .037; OR, 3.79; 95% CI, 1.08e13.26). When evaluating the QoR-40, both the global and domain scores at baseline were similar. Following the procedure, the postoperative emotional state domain declined for both groups, but the decline was significantly less in the dexamethasone group (P ¼ .042; r ¼ .21), indicating better quality of recovery (Table 3). Regarding the VAS scores for pain, these were slightly lower but not statistically different in the dexamethasone subjects. However, the VAS scale for nausea/vomiting was worse for placebo-treated subjects (P ¼ .042; r ¼ e0.26). Finally, although PONV scores were not significantly different, there were twice as many in

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the placebo arm with scores greater than 50, indicating clinically important symptoms. Anemia was noted in 1 dexamethasone-treated subject; no other adverse outcomes were recorded during the hospital course.

C OMMENT In this blinded, randomized controlled trial, use of dexamethasone 8 mg IV prior to vaginal reconstructive surgery resulted in less postoperative nausea and need for antiemetics as well as greater success with voiding trials. Furthermore, improvements in QOR were noted compared with a similar group receiving only placebo. Dexamethasone’s impact occurs through a variety of mechanisms to provide analgesic benefit and reduce nausea. Antiinflammatory properties

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TABLE 3

Scores on VAS, nursing verbal pain score, QoR-40, and PONV Scorea

Total (n [ 63)

Placebo (n [ 36)

Dexamethasone (n [ 27)

P valueb

VASc Postoperative pain level, cm

4.1 (2.5)

4.2 (2.7)

3.9 (2.3)

.61d

Postoperative nausea level, median (IQR), cm

0.6 (2.7)

0.7 (4.1)

0.4 (1.4)

.04e

3.8 (2.2)

3.6 (2.0)

4.1 (2.5)

.36d

3.8 (21.0)

3.3 (23.2)

4.4 (17.5)

.83d

Emotional state, median (IQR)

13.3 (21.1)

14.3 (16.8)

4.6 (20.1)

.04e

Physical independence

27.1 (28.0)

30.3 (22.2)

22.6 (18.1)

.14d

Average nursing verbal pain scorec

QoR-40, % change in scores, preoperative to postoperative Physical comfort

Psychological support, median (IQR)

0.0 (5.6)

0.0 (6.5)

0.0 (6.6)

.10

Pain

35.3 (48.4)

42.5 (48.3)

25.6 (47.8)

.19d

Global QoR-40

7.0 (11.0)

7.6 (11.8)

6.5 (9.9)

.70d

6 (9.5)

4 (11.4)

2 (7.4)

.47

PONV Total PONV >50, n, %

IQR, interquartile range; PONV, postoperative nausea and vomiting; QoR-40, Quality of Recovery; VAS, visual analog scale. a

Values are expressed as mean (SD) unless otherwise noted; b P values are for the Mann-Whitney rank sum test unless otherwise noted; c The range for possible scores is 0e10; d Unpaired Student t test; e P values are significant at the .05 level.

Pauls. Recovery following vaginal surgery using dexamethasone. Am J Obstet Gynecol 2015.

occur via inhibition of phospholipaseA2, cytokine production, and decreasing polymorphonuclear leukocytes as well as suppressing free oxygen radical formation, nitric oxide release, and postoperative edema.10 Another influence is by 5-hydoxytryptamine (serotonin) turnover in the neural tissue, prevention of release of 5-hydoxytryptamine in the gastrointestinal system, and potentiation centrally of other antiemetic effects.11 Moreover, diminished use of narcotic may improve awareness, whereas reduced vomiting leads to less diaphragmatic excursion and pressure in the abdominal area. We noted improvements in the QoR emotional state domain, which is reflective of the impact of dexamethasone. Additionally, better function on the voiding trials may be an indirect measure of overall well-being. Avoiding discharge with a catheter is beneficial, not only for patient satisfaction but also in reducing complications and morbidity.21 In combination with other antiemetics, or in single therapy, dexamethasone has been associated with less PONV in patients either having general anesthesia

or spinal anesthesia.8,9,11,12 Additionally, dexamethasone added to antiemetics for chemotherapy prophylaxis shows superior results.6,7 Similar to these studies, we noted less symptoms of PONV as recorded on the VAS scale and less use of rescue antiemetics for severe symptoms. Although the PONV scale scores did not show a difference, there were very few with clinically important nausea and vomiting overall. Given that placebo subjects were twice as likely to fall in that category, it may suggest medical relevance. Also noteworthy is the impact on patient return to voiding function, which remained following a logistic regression for antiincontinence procedure. It is possible that this was due to improved symptoms of nausea and recovery. Another theory is that dexamethasone has an independent effect on bladder wall inflammation, swelling, or sensitivity, which could have benefit to patients. Further work in this area is warranted. Whereas dexamethasone has received praise from anesthetists, both for its antiemetic properties and the reduction in airway swelling,5 there is potential for

immunosuppression and insulin resistance with steroid use. Hyperglycemia in the postoperative state can lead to increased infection, wound breakdown, and other morbidity. In our study, we did not enroll subjects with poorly controlled diabetes and did not record blood glucose levels on all patients. Therefore, we cannot fully comment on rates of hyperglycemia noted. However, no subjects had fever, ileus, or infections in the perioperative period. Furthermore, other research is supportive of dexamethasone use in perioperative subjects. A recent metaanalysis of 9 studies that utilized dexamethasone prior to laparoscopic cholecystectomy showed no increase in risk of infection, delay of wound healing, glucose intolerance, or adrenal suppression.11 Therefore it appears that short-term application of dexamethasone may be relatively safe, provided caution is exercised in patient selection. However, because we did follow up these patients regarding longer-term outcomes, it is not possible to comment on surgical results or prolapse recurrence.

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SGS Papers Strengths of our study include the blinded nature and randomization as well as the use of placebo. We included only subjects who were undergoing vaginal repairs involving intraperitoneal vault suspension and general anesthesia to ensure uniform technique. A postoperative antiemetic and pain regimen was also standardized based on our algorithms. We used several validated questionnaires to assess symptoms. Although we did achieve an adequate sample size, it was unfortunate that all the excluded patients were in the intervention arm, resulting in fewer treated subjects than anticipated. Because we had not revealed group allocations until analysis was complete, we did not know that would be the case. It is possible that this affected our ability to show differences in some of the outcomes measured. Additionally, despite randomization, there was a significantly higher ASA class in the dexamethasone group. Prior studies have shown that greater ASA class may be linked to poorer QOR,3 and this could have had an impact on our ability to show a larger difference. Thus, we believe we have strong evidence to suggest this medication may be of benefit to women undergoing vaginal reconstruction. Notwithstanding, we recognize that the model and timing for our randomization was a limitation of our design. Although patients who were undergoing a variety of vaginal procedures including hysterectomy and suburethral sling could be enrolled, we do not implant transvaginal mesh. Moreover, we did not include other approaches such as robotic sacrocolpopexy, which has an impact on the generalizability of our data. Nevertheless, we believe the information here is clinically relevant for vaginal surgeons and renders our data less subject to confounders. Dexamethasone improves PONV and quality of recovery and may enhance results with postoperative voiding trials. It is a safe and easily implemented medication for the preoperative anesthesia

ajog.org regimen. With outcomes and satisfaction being pivotal to providers, this can be a useful tool to enhance our female patients’ convalescence after surgery. Future research regarding possible the impact of dexamethasone on bladder function postoperatively, as well as a longer-term impact on surgical results and prolapse recurrence, may be of use to providers in this arena. ACKNOWLEDGMENTS We acknowledge Janine Benbouajili, MA, and Justin Gregg, MA, for their assistance with data analysis. This study had a National Clinical Trial Identifier of 02073734 (http://clinicaltrials.gov/ show/NCT02073734).

REFERENCES 1. Wu CL, Richman JM. Postoperative pain and quality of recovery. Curr Opin Anaesthesiol 2004;17:455-60. 2. Myles PS, Weitkamp B, Jones K, et al. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth 2000;84:11-5. 3. Myles PS, Reeves MD, Anderson H, et al. Measurement of quality of recovery in 5672 patients after anaesthesia and surgery. Anaesth Intens Care 2000;28:276-80. 4. Myles PS, Williams DL, Hendrata M, et al. Patient satisfaction after anaesthesia and surgery: results of a prospective survey of 10,811 patients. Br J Anaesth 2000;84:6-10. 5. Jones R, Daunt M. Should anaesthetists routinely give dexamethasone as a perioperative antiemetic? Br J Hosp Med (Lond) 2014;75: 118. 6. Ahsan K, Abbas N, Naqvi SM, et al. Comparison of efficacy of ondansetron and dexamethasone combination and ondansetron alone in preventing postoperative nausea and vomiting after laparoscopic cholecystectomy. JPMA J Pak Med Assoc 2014;64:242-6. 7. Rapoport BL. Efficacy of a triple antiemetic regimen with aprepitant for the prevention of chemotherapy-induced nausea and vomiting: effects of gender, age, and region. Curr Med Res Opin 2014;30:1875-81. 8. Cardoso MM, Leite AO, Santos EA, et al. Effect of dexamethasone on prevention of postoperative nausea, vomiting and pain after caesarean section: a randomised, placebocontrolled, double-blind trial. Eur J Anaesthesiol 2013;30:102-5.

718.e7 American Journal of Obstetrics & Gynecology NOVEMBER 2015

9. Tobi KU, Imarengiaye CO, Amadasun FE. The effects of dexamethasone and metoclopramide on early and late postoperative nausea and vomiting in women undergoing myomectomy under spinal anaesthesia. Niger J Clin Pract 2014;17:449-55. 10. De Oliveira GS Jr, Ahmad S, Fitzgerald PC, et al. Dose ranging study on the effect of preoperative dexamethasone on postoperative quality of recovery and opioid consumption after ambulatory gynaecological surgery. Br J Anaesth 2011;107:362-71. 11. Si XY, Wu LP, Li XD, et al. Dexamethasone combined with other antiemetics for prophylaxis after laparoscopic cholecystectomy. Asian J Surg 2015;38:21-7. 12. Jokela RM, Ahonen JV, Tallgren MK, et al. The effective analgesic dose of dexamethasone after laparoscopic hysterectomy. Anesth Analg 2009;109:607-15. 13. Collins SA, Joshi G, Quiroz LH, et al. Pain management strategies for urogynecologic surgery: a review. Female Pelvic Med Reconstr Surg 2014;20:310-5. 14. Bump RC, Mattiasson A, Bo K, et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 1996;175:10-7. 15. Baggish MS, Karram MM. Atlas of pelvic anatomy and gynecologic surgery. St Louis, MO: Elsevier Saunders; 2011. 16. Kindler CH, Harms C, Amsler F, et al. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients’ anesthetic concerns. Anesth Analg 2000;90:706-12. 17. Gallagher EJ, Bijur PE, Latimer C, et al. Reliability and validity of a visual analog scale for acute abdominal pain in the ED. Am J Emerg Med 2002;20:287-90. 18. Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth 2012;108:423-9. 19. Wengritzky R, Mettho T, Myles PS, et al. Development and validation of a postoperative nausea and vomiting intensity scale. Br J Anaesth 2010;104:158-66. 20. Allen ML, Leslie K, Jansen N. Validation of the postoperative nausea and vomiting intensity score in gynaecological patients. Anaesth Intens Care 2011;39:73-8. 21. Hakvoort RA, Elberink R, Vollebregt A, et al. How long should urinary bladder catheterisation be continued after vaginal prolapse surgery? A randomised controlled trial comparing short term versus long term catheterisation after vaginal prolapse surgery. BJOG 2004;111: 828-30.

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