Skip to content

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

Yanan Wu, Yaning Yang, Xiaomei Wang, Li Sun, Yunpeng Hei, Yuhua Zou, Zhenhai Ye, Zhi Yu

BMC Anesthesiology July 1, 2025 DOI: 10.1186/s12871-025-03180-1 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial Placebo-controlled Double-blind Peer reviewed
Sample size 86
Population Patients aged ≥ 18 years, ASA I to III, BMI 18 to 30 kg/m², undergoing laparoscopic cholecystectomy
Intervention Esketamine
Dose 0.5 mg/kg/h
Duration Intraoperative infusion, follow-up through postoperative day 3
Topics Esketamine
Keywords Laparoscopic cholecystectomy Postoperative sleep disturbance Ketamine derivative Anesthetic agent Sleep disruption Post-surgical sleep issues Insomnia Sleep quality Pain management Analgesia Opioid reduction Postoperative pain Postoperative care Post-surgical recovery Patient outcomes Minimally invasive surgery
Citations 9
Key findings Intraoperative esketamine infusion significantly lowered the incidence of postoperative sleep disturbance on each of the first three postoperative days compared with placebo.

Abstract

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. 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. 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. 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. Chinese Clinical Trial Registry (ChiCTR2400083826).

Comparable studies

Other randomized controlled trials on esketamine, most cited first.

Study Year Design Participants
Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study Adults with moderate to severe nonpsychotic depression and a history of nonresponse to... 2019 Phase 3, double-blind, active-controlled, multicenter randomized controlled trial n = 227
Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression Adults with treatment-resistant depression who achieved stable remission or stable... 2019 Phase 3, multicenter, double-blind, randomized withdrawal study n = 297
Efficacy and Safety of Intranasal Esketamine Adjunctive to Oral Antidepressant Therapy in Treatment-Resistant Depression Adults with DSM-IV-TR diagnosis of major depressive disorder and history of inadequate... 2017 Phase 2, double-blind, doubly randomized, delayed-start, placebo-controlled study n = 67
Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study Depressed patients at imminent risk for suicide 2018 Randomized controlled trial n = 68
Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1) Adults with moderate-to-severe depression and nonresponse to at least two... 2019 Randomized controlled trial n = 346

Citations in the library

Explore topics