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Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial
Muscular Tissue Oxygen Saturation and Posthysterectomy Nausea and Vomiting: The iMODIPONV Randomized Controlled Trial.
- Gang Li, Dan-Dan Tian, Xu Wang, Xiaoxian Feng, Wenyu Zhang, Ju Bao, Dong-Xin Wang, Yan-Qiu Ai, Ya Liu, Mengyuan Zhang, Mingjun Xu, Dong-Liang Mu, Xu Zhao, Feng Dai, Jian-Jun Yang, Xiangming Che, David Yanez, Xiangyang Guo, Lingzhong Meng, and iMODIPONV Research Group.
- From the Department of Anesthesiology, Peking University Third Hospital, Beijing, China (G.L., X.G.) the Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China (D.-D.T., Y.-Q.A., J.-J.Y.) the Department of Anesthesiology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong Province, China (X.W., M.Z.) the Department of Anesthesiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China (X.F., Y.L.) the Department of Anesthesiology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China (W.Z., M.X., X.C.) the Department of Anesthesiology, Peking University First Hospital, Beijing, China (J.B., D.-X.W., D.-L.M.) the Department of Biostatistics, Yale University School of Public Health, Yale Center for Analytical Sciences, New Haven, Connecticut (F.D.) the Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut (X.Z., D.Y., L.M.).
- Anesthesiology. 2020 Aug 1; 133 (2): 318-331.
BackgroundSuboptimal tissue perfusion and oxygenation during surgery may be responsible for postoperative nausea and vomiting in some patients. This trial tested the hypothesis that muscular tissue oxygen saturation-guided intraoperative care reduces postoperative nausea and vomiting.MethodsThis multicenter, pragmatic, patient- and assessor-blinded randomized controlled (1:1 ratio) trial was conducted from September 2018 to June 2019 at six teaching hospitals in four different cities in China. Nonsmoking women, 18 to 65 yr old, and having elective laparoscopic surgery involving hysterectomy (n = 800) were randomly assigned to receive either intraoperative muscular tissue oxygen saturation-guided care or usual care. The goal was to maintain muscular tissue oxygen saturation, measured at flank and on forearm, greater than baseline or 70%, whichever was higher. The primary outcome was 24-h postoperative nausea and vomiting. Secondary outcomes included nausea severity, quality of recovery, and 30-day morbidity and mortality.ResultsOf the 800 randomized patients (median age, 50 yr [range, 27 to 65]), 799 were assessed for the primary outcome. The below-goal muscular tissue oxygen saturation area under the curve was significantly smaller in patients receiving muscular tissue oxygen saturation-guided care (n = 400) than in those receiving usual care (n = 399; flank, 50 vs. 140% · min, P < 0.001; forearm, 53 vs. 245% · min, P < 0.001). The incidences of 24-h postoperative nausea and vomiting were 32% (127 of 400) in the muscular tissue oxygen saturation-guided care group and 36% (142 of 399) in the usual care group, which were not significantly different (risk ratio, 0.89; 95% CI, 0.73 to 1.08; P = 0.251). There were no significant between-group differences for secondary outcomes. No harm was observed throughout the study.ConclusionsIn a relatively young and healthy female patient population, personalized, goal-directed, muscular tissue oxygen saturation-guided intraoperative care is effective in treating decreased muscular tissue oxygen saturation but does not reduce the incidence of 24-h posthysterectomy nausea and vomiting.
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