Data Sheet 2_Effect of total intravenous opioid-free anesthesia on quality of recovery following gynecological laparoscopy: protocol for a multicenter, randomized, double-blind, controlled trial.docx

BackgroundWhether opioid-free anesthesia (OFA) improves postoperative quality of recovery remains uncertain. This study aims to compare the effects of an intraoperative OFA protocol with traditional intraoperative opioid-based anesthesia (OBA) on recovery quality in patients undergoing gynecological laparoscopic surgery.
MethodsThis multicenter, randomized, double-blind, controlled trial will include 300 adult women scheduled for elective gynecological laparoscopic surgery at five tertiary hospitals in China. Patients will be randomized in a 1:1 ratio to either the OFA group (dexmedetomidine, esketamine, and lidocaine) or OBA group (sufentanil), stratified by study center. Following anesthesia induction, all patients will receive bilateral transversus abdominis plane blocks and propofol-based total intravenous anesthesia. The primary outcome is postoperative quality of recovery at 24 h, assessed using the Quality of Recovery−15 (QoR-15) questionnaire. Secondary outcomes include incidence of postoperative nausea and vomiting, QoR-15 scores at 48 and 72 h, numeric rating scale pain scores at rest and on coughing, cumulative opioid consumption, health-related quality of life and incidence of chronic pain at 3 months. Adverse events include hypotension, bradycardia, hypertension, tachycardia, oversedation, desaturation, dizziness, headache, ileus, hyperalgesia, psychiatric related side effects (hallucinations, agitation, nightmares, or delirium) occurring intraoperatively or during hospitalization. The primary analysis will be conducted according to the modified intention-to-treat principle.
DiscussionWe hypothesize that an intraoperative intravenous OFA regimen will enhance recovery quality compared with a traditional intraoperative OBA regimen in women undergoing gynecological laparoscopic surgery. The findings are expected to inform evidence-based optimization of anesthetic strategies in this surgical population.
Trial registration numberhttps://www.chictr.org.cn, identifier (ChiCTR2500106392).