Rachel N Pauls1, Catrina C Crisp2, Susan H Oakley3, Lauren B Westermann2, Donna Mazloomdoost2, Steven D Kleeman2, Vivian Ghodsi4, Maria Victoria Estanol5. 1. Division of Urogynecology, Department of Obstetrics and Gynecology, TriHealth Good Samaritan Hospital, Cincinnati, OH. Electronic address: Rachel_Pauls@trihealth.com. 2. Division of Urogynecology, Department of Obstetrics and Gynecology, TriHealth Good Samaritan Hospital, Cincinnati, OH. 3. St. Elizabeth Physicians, Division of Female Pelvic Medicine and Reconstructive Surgery, Fort Thomas, KY. 4. Hatton Research Institute, TriHealth Good Samaritan Hospital, Cincinnati, OH. 5. William Beaumont Hospital/Oakland University School of Medicine, Royal Oak, MI.
Abstract
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 = .030). Postoperatively, more patients in the placebo group required promethazine as a rescue antiemetic for control of their nausea/vomiting (11 vs 2; P = .029). Placebo subjects also failed their voiding trials more frequently, which remained following a logistic regression controlling for suburethral sling (30 vs 15; P = .037). Regarding the QoR-40 following surgery, the emotional state domain declined less in dexamethasone patients (-14.3, interquartile range [IQR], 16.8 vs -4.6, IQR, 20.1; P = .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 = .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 = .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.
RCT Entities:
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 = .030). Postoperatively, more patients in the placebo group required promethazine as a rescue antiemetic for control of their nausea/vomiting (11 vs 2; P = .029). Placebo subjects also failed their voiding trials more frequently, which remained following a logistic regression controlling for suburethral sling (30 vs 15; P = .037). Regarding the QoR-40 following surgery, the emotional state domain declined less in dexamethasonepatients (-14.3, interquartile range [IQR], 16.8 vs -4.6, IQR, 20.1; P = .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 = .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 = .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.
Authors: Elisa R Trowbridge; Caitlin N Dreisbach; Bethany M Sarosiek; Catherine Page Dunbar; Sarah Larkin Evans; Lee Anne Hahn; Kathie L Hullfish Journal: Int Urogynecol J Date: 2017-09-04 Impact factor: 2.894
Authors: Stephanie Weibel; Gerta Rücker; Leopold Hj Eberhart; Nathan L Pace; Hannah M Hartl; Olivia L Jordan; Debora Mayer; Manuel Riemer; Maximilian S Schaefer; Diana Raj; Insa Backhaus; Antonia Helf; Tobias Schlesinger; Peter Kienbaum; Peter Kranke Journal: Cochrane Database Syst Rev Date: 2020-10-19
Authors: Constantin M Durnea; Vasilios Pergialiotis; James M N Duffy; Lina Bergstrom; Abdullatif Elfituri; Stergios K Doumouchtsis Journal: Int Urogynecol J Date: 2018-10-22 Impact factor: 2.894