Effect of intraoperative low-dose esketamine infusion on postoperative sleep disturbance after laparoscopic cholecystectomy: a randomized clinical trial.

Abstract

Background: Postoperative sleep disturbance (PSD) is a common surgical complication. In this study, we investigated the effect of intraoperative esketamine infusion on the incidence of PSD in patients who underwent laparoscopic cholecystectomy.

Methods: A single-center, double-blinded, placebo-controlled randomized clinical trial was perfomed from May to August 2024 at the People's Hospital of Ningxia Hui Autonomous Region. Study participants included patients aged ≥ 18 years, ASA classification of I to III, BMI of 18 to 30 kg/m² and underwent laparoscopic cholecystectomy. Patients were randomly assigned to esketamine group or placebo group using a random number table method. Patients in the esketamine group received continuous intraoperative infusion of esketamine, 0.5 mg/kg/h while those in the placebo group were given an equal volume of normal saline. The primary outcome was PSD incidence within 1-3 postoperative days (PODs). PSD was defined as numerical rating scale score of 6 or higher or Athens Insomnia Scale score of 6 or higher. Secondary outcomes were postoperative pain (using visual analog scale), intraoperative remifentanil consumption, postoperative adverse reactions, and PSD-related risk factors.

Results: Eighty-six patients were randomly assigned to esketamine group (n = 43; mean [SD] age, 47.9 [9.4] years) and placebo groups (n = 43; mean [SD] age, 49.7 [15.1] years). The incidence of PSD in the esketamine group was significantly lower than in the control group on POD 1 (58.1% vs. 81.4%;​ odds ratio [OR], 0.32 [95%Cl, 0.12-0.84]; P = 0.019) and POD 2 (11.6% vs. 44.2%; OR, 0.17 [95%Cl, 0.06-0.50]; P = 0.001) and POD3 (2.3% vs. 18.6%; OR, 0.10 [95%Cl, 0.01-0.87]; P = 0.035). Postoperative pain score and intraoperative remifentanil consumption in the esketamine group were lower than those in the placebo group (all P < 0.05). There was no difference in postoperative adverse reactions between the two groups. Multivariate logistic regression analysis showed that operation duration (P = 0.049), ASA grade (P = 0.044), and drain insertion (P = 0.021) were independent risk factors for PSD.

Conclusion: Intraoperative infusion of low-dose esketamine can prevent the incidence of PSD in patients undergoing laparoscopic cholecystectomy. Further studies are required to confirm these results.

Trial registration: Chinese Clinical Trial Registry (ChiCTR2400083826).