Anaesthesia, critical care & pain medicine · 2026
Opioid-free versus opioid-based anesthesia for quality of recovery following laparoscopic hysterectomy: a randomized controlled non-inferiority trial.
СтатьяРандомизированное исследованиеEquivalence TrialСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Zhuo Yifen, Dai Dongsheng, Qian Bin, Yang Ying, Zheng Ting, Gao Weitao, Lin Wenjun, Lin Jie
Аннотация
BACKGROUND: Laparoscopic gynecological surgery traditionally relies on opioids for general anesthesia, yet these medications frequently cause postoperative nausea and vomiting (PONV), respiratory depression, and delayed recovery. This randomized trial evaluated whether opioid-free anesthesia maintains recovery quality while reducing complications in women undergoing laparoscopic hysterectomy.
METHODS: We randomized 110 women (American Society of Anesthesiologists physical status I-II) undergoing elective laparoscopic hysterectomy to receive either opioid-free anesthesia (dexmedetomidine/esketamine induction; dexmedetomidine/sevoflurane maintenance) or opioid-based anesthesia (sufentanil induction; remifentanil/sevoflurane maintenance). The primary outcome was recovery quality at 24 h, measured using the Quality of Recovery-15 (QoR-15) questionnaire. Non-inferiority was defined as a between-group difference of less than 6 points. Secondary outcomes included pain scores, morphine consumption, PONV, and adverse events.
RESULTS: All 110 patients completed follow-up with 96% protocol adherence. The opioid-free group demonstrated non-inferior QoR-15 scores: median 123 (IQR 115-127) versus 121 (IQR 114-125) for opioid-based anesthesia, with a 2.0-point median difference (95% CI -1.0-4.0, p < 0.001). Postoperative morphine consumption was comparable between groups (8 mg [IQR 8-12] vs. 10 mg [IQR 8-12], median difference p = 0.315). The opioid-free group exhibited reduced PONV incidence (10/55 [18.2%] vs. 20/55 [36.4%]; relative risk 0.50, 95% CI 0.26-0.97, p = 0.032) and severity (odds ratio 0.39, 95% CI 0.16-0.94, p = 0.035). No serious adverse events occurred.
CONCLUSION: Opioid-free anesthesia demonstrated non-inferiority to opioid-based anesthesia for recovery quality while reducing the incidence and severity of PONV. These findings support opioid-free protocols as effective alternatives for laparoscopic hysterectomy, particularly for patients at high PONV risk.
REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2300071297).
METHODS: We randomized 110 women (American Society of Anesthesiologists physical status I-II) undergoing elective laparoscopic hysterectomy to receive either opioid-free anesthesia (dexmedetomidine/esketamine induction; dexmedetomidine/sevoflurane maintenance) or opioid-based anesthesia (sufentanil induction; remifentanil/sevoflurane maintenance). The primary outcome was recovery quality at 24 h, measured using the Quality of Recovery-15 (QoR-15) questionnaire. Non-inferiority was defined as a between-group difference of less than 6 points. Secondary outcomes included pain scores, morphine consumption, PONV, and adverse events.
RESULTS: All 110 patients completed follow-up with 96% protocol adherence. The opioid-free group demonstrated non-inferior QoR-15 scores: median 123 (IQR 115-127) versus 121 (IQR 114-125) for opioid-based anesthesia, with a 2.0-point median difference (95% CI -1.0-4.0, p < 0.001). Postoperative morphine consumption was comparable between groups (8 mg [IQR 8-12] vs. 10 mg [IQR 8-12], median difference p = 0.315). The opioid-free group exhibited reduced PONV incidence (10/55 [18.2%] vs. 20/55 [36.4%]; relative risk 0.50, 95% CI 0.26-0.97, p = 0.032) and severity (odds ratio 0.39, 95% CI 0.16-0.94, p = 0.035). No serious adverse events occurred.
CONCLUSION: Opioid-free anesthesia demonstrated non-inferiority to opioid-based anesthesia for recovery quality while reducing the incidence and severity of PONV. These findings support opioid-free protocols as effective alternatives for laparoscopic hysterectomy, particularly for patients at high PONV risk.
REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2300071297).