From the Department of Anesthesia, The Second Xiangya Hospital of Central South University, Changsha, Hunan (FZ, YC, LC), Department of Anesthesia, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang (FZ) and Department of Anesthesia, Guilin Hospital of the Second Xiangya Hospital, Central South University, Guilin, Guangxi, China (LC).
Eur J Anaesthesiol. 2023 Aug 1;40(8):542-551. doi: 10.1097/EJA.0000000000001784. Epub 2023 Jun 29.
It remains to be determined whether opioid-free anaesthesia (OFA) is consistently effective for different types of surgery.
The current study hypothesised that OFA could effectively inhibit intraoperative nociceptive responses, reduce side effects associated with opioid use, and improve the quality of recovery (QoR) in endoscopic sinus surgery (ESS).
A multicentre randomised controlled study.
Seven hospitals participated in this multicentre trial from May 2021 to December 2021.
Of the 978 screened patients who were scheduled for elective ESS, 800 patients underwent randomisation, and 773 patients were included in the analysis; 388 patients in the OFA group and 385 patients in the opioid anaesthesia group.
The OFA group received balanced anaesthesia with dexmedetomidine, lidocaine, propofol and sevoflurane; the opioid anaesthesia group received opioid-based balanced anaesthesia using sufentanil, remifentanil, propofol and sevoflurane.
The primary outcome was 24-h postoperative QoR as evaluated by the Quality of Recovery-40 questionnaire. The key secondary outcomes were episodes of postoperative pain and postoperative nausea and vomiting (PONV).
A significant difference ( P = 0.0014) in the total score of 24-h postoperative Quality of Recovery-40 was found between the OFA group, median [interquartile range], 191 [185 to 196] and the opioid anaesthesia group (194 [187 to 197]). There were significant differences between the opioid anaesthesia group and the OFA group in the numerical rating scale score for pain after surgery at 30 min ( P = 0.0017), 1 h ( P = 0.0052), 2 h ( P = 0.0079) and 24 h ( P = 0.0303). The difference in the area under the curve of pain scale scores between the OFA group (24.2 [3.0 to 47.5]) and the opioid anaesthesia group (11.5 [1.0 to 39.0]) was significant ( P = 0.0042). PONV occurred in 58 of 385 patients (15.1%) in the opioid anaesthesia group compared with 27 of 388 patients (7.0%) in the OFA group, suggesting the incidence of PONV in the OFA group was significantly lower than in the opioid anaesthesia group ( P = 0.0021).
OFA can provide good intraoperative analgesia and postoperative recovery quality as effectively as conventional opioid anaesthesia in patients undergoing ESS. OFA can be an alternative option in the pain management of ESS.
The study was registered at the Chinese Clinical Trial Registry (ChiCTR2100046158; registry URL: http://www.chictr.org.cn/enIndex.aspx .).
阿片类药物-free 麻醉（OFA）是否对不同类型的手术都有效仍有待确定。
本研究假设 OFA 可有效抑制术中伤害性反应，减少阿片类药物使用相关的副作用，并提高内镜鼻窦手术（ESS）的恢复质量（QoR）。
多中心随机对照研究。
七家医院于 2021 年 5 月至 2021 年 12 月参与了这项多中心试验。
在计划接受择期 ESS 的 978 例筛查患者中，800 例患者进行了随机分组，773 例患者纳入分析；OFA 组 388 例，阿片类药物麻醉组 385 例。
OFA 组接受右美托咪定、利多卡因、丙泊酚和七氟醚的平衡麻醉；阿片类药物麻醉组接受舒芬太尼、瑞芬太尼、丙泊酚和七氟醚的阿片类药物平衡麻醉。
使用 40 项术后恢复质量问卷（Quality of Recovery-40）评估术后 24 小时 QoR，这是主要结局。关键次要结局为术后疼痛和术后恶心呕吐（PONV）的发作情况。
OFA 组术后 24 小时 Quality of Recovery-40 总评分[中位数（四分位数间距）]为 191（185 至 196），阿片类药物麻醉组为 194（187 至 197），两组间存在显著差异（ P = 0.0014）。阿片类药物麻醉组与 OFA 组术后 30 分钟（ P = 0.0017）、1 小时（ P = 0.0052）、2 小时（ P = 0.0079）和 24 小时（ P = 0.0303）的数字评分量表疼痛评分存在显著差异。OFA 组（24.2 [3.0 至 47.5]）和阿片类药物麻醉组（11.5 [1.0 至 39.0]）疼痛评分曲线下面积的差异具有统计学意义（ P = 0.0042）。阿片类药物麻醉组 385 例患者中有 58 例（15.1%）发生 PONV，OFA 组 388 例患者中有 27 例（7.0%）发生 PONV，提示 OFA 组 PONV 的发生率显著低于阿片类药物麻醉组（ P = 0.0021）。
OFA 可在 ESS 患者中提供与常规阿片类药物麻醉同样有效的术中镇痛和术后恢复质量。OFA 可作为 ESS 疼痛管理的一种替代方案。
该研究在中国临床试验注册中心注册（ChiCTR2100046158；注册网址：http://www.chictr.org.cn/enIndex.aspx）。
