Drug design, development and therapy · 2025
Effects of Glycopyrronium Bromide as an Adjuvant Treatment in the Prevention of Nausea and Vomiting After Abdominal, Thyroid, and Breast Surgery: A Multicenter Randomized Controlled Trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Chen Jie, Piao Guangxi, Luan Guohui, Yu Yunming, Zheng Wei, Li Yue, Zhang Chao, Duan Yunzhen, Zhao Min, Zhang Yong, Xiang Wei, Cheng Lu, Ji Chengcheng, Duan Guangyou, Huang He
Аннотация
BACKGROUND: Effective methods for the prevention of postoperative nausea and vomiting remain to be found. Building upon previous evidence, we examined whether glycopyrrolate bromide had a preventive effect on nausea and vomiting when used as an adjuvant treatment.
METHODS: In 11 participating hospitals, patients who were scheduled to receive gynecological (n=123), gastrointestinal (n=201), thyroid (n=93), and breast surgery (n=51) under general anesthesia and received postoperative opioids were randomly allocated to receive 4 mg dexamethasone and 4 mg tropisetron (Group C) or 4 mg dexamethasone and 4 mg tropisetron combined with 0.2 mg glycopyrrolate bromide (Group G). The primary outcome of postoperative nausea and vomiting was assessed. The secondary outcomes included the incidences of significant nausea and vomiting (defined based on a rating scale of intensity ≥ 4), vomiting, and extra intervention.
RESULTS: In total, 471 patients (234 in Group G and 237 in Group C) were included in the final analysis. The incidence of postoperative nausea and vomiting in Group G was lower than that in Group C (27.8% vs 43.0%, odds rate=0.65, 95% confidence interval =0.50-0.83, P=0.001). Furthermore, the incidences of significant nausea and vomiting (14.1% vs 27.8%, odds rate=0.50, 95% confidence interval=0.35-0.74, P<0.001), vomiting (7.3% vs 15.6%, OR=0.46, 95% confidence interval=0.27-0.80, P=0.004) and extra intervention (9.4% vs 17.7%, odds rate=0.53, 95% confidence interval=0.33-0.86, P=0.008) in Group G were all significantly lower than those in Group C. The two groups showed no significant difference in adverse events.
CONCLUSION: The intravenous administration of 0.2 mg glycopyrronium bromide at the end of surgery can be an effective adjuvant treatment strategy for prevention of nausea and vomiting in patients undergoing surgery under general anesthesia and receiving postoperative opioids.
TRIAL REGISTRATION: The Hospital Ethics Committee of the Second Affiliated Hospital, Chongqing Medical University (Approval ID: 2022-14-1) approved this study. This trial was registered with Identifier NCT05331651 on ClinicalTrials.gov.
METHODS: In 11 participating hospitals, patients who were scheduled to receive gynecological (n=123), gastrointestinal (n=201), thyroid (n=93), and breast surgery (n=51) under general anesthesia and received postoperative opioids were randomly allocated to receive 4 mg dexamethasone and 4 mg tropisetron (Group C) or 4 mg dexamethasone and 4 mg tropisetron combined with 0.2 mg glycopyrrolate bromide (Group G). The primary outcome of postoperative nausea and vomiting was assessed. The secondary outcomes included the incidences of significant nausea and vomiting (defined based on a rating scale of intensity ≥ 4), vomiting, and extra intervention.
RESULTS: In total, 471 patients (234 in Group G and 237 in Group C) were included in the final analysis. The incidence of postoperative nausea and vomiting in Group G was lower than that in Group C (27.8% vs 43.0%, odds rate=0.65, 95% confidence interval =0.50-0.83, P=0.001). Furthermore, the incidences of significant nausea and vomiting (14.1% vs 27.8%, odds rate=0.50, 95% confidence interval=0.35-0.74, P<0.001), vomiting (7.3% vs 15.6%, OR=0.46, 95% confidence interval=0.27-0.80, P=0.004) and extra intervention (9.4% vs 17.7%, odds rate=0.53, 95% confidence interval=0.33-0.86, P=0.008) in Group G were all significantly lower than those in Group C. The two groups showed no significant difference in adverse events.
CONCLUSION: The intravenous administration of 0.2 mg glycopyrronium bromide at the end of surgery can be an effective adjuvant treatment strategy for prevention of nausea and vomiting in patients undergoing surgery under general anesthesia and receiving postoperative opioids.
TRIAL REGISTRATION: The Hospital Ethics Committee of the Second Affiliated Hospital, Chongqing Medical University (Approval ID: 2022-14-1) approved this study. This trial was registered with Identifier NCT05331651 on ClinicalTrials.gov.