The effect of opioid-free anesthesia on the quality of recovery after gynecological laparoscopy: study protocol for a prospective randomized controlled trial

Abstract

Background Because of the indiscriminate use of opioids during the perioperative period, opioid-free anesthesia (OFA) has been increasingly required. Nevertheless, the studies on the detailed techniques and effects of OFA are not sufficient. The Quality of Recovery-40 (QoR-40) questionnaire is a validated assessment tool for measuring recovery from general anesthesia. However, no study has used the QoR-40 to determine if OFA leads to better recovery than standard general anesthesia. Therefore, we aim to perform this study to determine the effects of OFA using dexmedetomidine and lidocaine on the quality of recovery as well as the various postoperative outcomes. Methods The participants (n = 78) will be allocated to one of the two groups; the study group will receive bolus and infusion of dexmedetomidine and lidocaine, and the control group will receive remifentanil infusion during general anesthesia for gynecological laparoscopy. The other processes including anesthetic and postoperative care will be performed similarly in the two groups. Intraoperative hemodynamic, anesthetic, and nociceptive variables will be recorded. Postoperative outcomes such as QoR-40, pain severity, and opioid-related side effects will be assessed. Additionally, an ancillary cytokine study (inflammatory cytokine, stress hormone, and reactive oxygen species) will be performed during the study period. Discussion This will be the first study to determine the effect of OFA, using the combination of dexmedetomidine and lidocaine, on the quality of recovery after gynecological laparoscopy compared with standard general anesthesia using remifentanil. The findings from this study will provide scientific and clinical evidence on the efficacy of OFA. Trial registration ClinicalTrials.gov NCT04409964. Registered on 28 May 2020

Impact of Opioid-Free Anesthesia on Postoperative Quality of Recovery in Patients After Laparoscopic Cholecystectomy-A Randomized Controlled Trial

“… 12 In terms of physical discomfort and physical independence, the current results are consistent with the findings from a recent study, which revealed that the incidence of PONV in Group OA after gynecological surgery was higher than in Group OFA. 13 Combined with our results, we speculate that intraoperative opioid use might increase the risk of PONV and may result in poor sleep quality and worse diet quality. Esketamine is a valid analgesic alternative to opioids to avoid opioid-related nausea and vomiting in the postoperative setting.…”

The Effect of Opioid-Free Anesthesia on the Quality of Recovery After Gynecological Laparoscopy: A Prospective Randomized Controlled Trial

“…Full details of the study protocol have been published previously. 18 Written informed consent was obtained from all participating patients before inclusion in the study. The study is reported according to the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement and the CONSORT Patient-Reported Outcomes (CONSORT PRO) Extension.…”

Effect of Dexmedetomidine on Recovery from Anesthesia in Gynecologic Laparoscopic Surgery

“…Moreover, the Ramsay scores in the experimental group were significantly higher than those in the observation group after treatment, indicating that dexmedetomidine provides more sedative benefits in patients undergoing laparoscopic gynecological surgery. Song et al, [21] indicated that 0.6 µg/kg of dexmedetomidine administered 30 min before induction of anesthesia could effectively ensure the intraoperative hemodynamic stability of patients and well inhibit the extubation reflex.…”