Zhu Ya-Juan, Wang Dan, Long Yu-Qin, Qian Long, Liu Hong, Ji Fu-Hai, Peng Ke
Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, 215006, Jiangsu, China.
Institute of Anesthesiology, Soochow University, Suzhou, Jiangsu, China.
Perioper Med (Lond). 2023 Jul 14;12(1):38. doi: 10.1186/s13741-023-00329-9.
Postoperative nausea and vomiting (PONV) are common after general anesthesia and surgery. This study aims to compare the effects of total intravenous opioid-free anesthesia (OFA) with conventional opioid-based anesthesia (OBA) on PONV in patients following treatments for wounds of lower extremities.
This randomized, double-blind, crossover trial will include a total of 72 adult patients scheduled for at least two separate surgical treatments of lower extremity wounds under general anesthesia. Patients will be randomized to 1 of 2 anesthesia sequences of OFA and OBA. Patients in sequence 1 will receive OFA in the first treatment procedure and OBA in the second procedure, while patients in sequence 2 will receive the two anesthesia regimens in the reverse order. The washout period is at least 5 days. OFA will be delivered with intravenous esketamine, lidocaine, dexmedetomidine, and propofol. OBA will be delivered with intravenous sufentanil and propofol. The primary endpoint is the incidence of PONV within the first 48 h postoperatively. The secondary endpoints are the severity of PONV, antiemetic rescue therapy, postoperative pain scores, the worst pain, need for rescue analgesia, postoperative sedation, hypotension, bradycardia, hypertension, tachycardia, hypoxemia, psychotomimetic or dissociative effects, time to extubation, and length of postanesthesia care unit stay. Patients who complete two surgical procedures with designated anesthesia regimens will be included in the final analyses.
This crossover trial will determine whether total intravenous OFA reduces PONV in patients following treatments for lower extremity wounds. The results of this trial will also represent an important step to understand the benefits and possible risks of OFA in surgical patients.
Chinese Clinical Trial Registry (ChiCTR2200061511).
全身麻醉和手术后，术后恶心呕吐（PONV）很常见。本研究旨在比较全静脉无阿片类麻醉（OFA）与传统阿片类麻醉（OBA）对下肢伤口治疗患者PONV的影响。
这项随机、双盲、交叉试验将纳入总共72名成年患者，这些患者计划在全身麻醉下接受至少两次单独的下肢伤口手术治疗。患者将被随机分为OFA和OBA两种麻醉顺序中的一种。顺序1的患者在第一次治疗过程中接受OFA，在第二次过程中接受OBA，而顺序2的患者将以相反顺序接受两种麻醉方案。洗脱期至少为5天。OFA将通过静脉注射艾司氯胺酮、利多卡因、右美托咪定和丙泊酚给药。OBA将通过静脉注射舒芬太尼和丙泊酚给药。主要终点是术后48小时内PONV的发生率。次要终点包括PONV的严重程度、止吐抢救治疗、术后疼痛评分、最严重疼痛、抢救镇痛需求、术后镇静、低血压、心动过缓、高血压、心动过速、低氧血症、拟精神或解离效应、拔管时间以及麻醉后监护病房停留时间。完成两种指定麻醉方案手术的患者将纳入最终分析。
这项交叉试验将确定全静脉OFA是否能降低下肢伤口治疗患者的PONV。该试验的结果也将是了解OFA在手术患者中的益处和可能风险的重要一步。
中国临床试验注册中心（ChiCTR2200061511）。
