What type of study is this?

This is a Human Clinical Trial study (also classified as: Pre-Registered Trial).

May 7, 2026BMJ Open0 citationsOpen Access

Effect of evening dexmedetomidine nasal spray on postoperative sleep disturbance in patients undergoing laparoscopic cholecystectomy: protocol for a multicentre, prospective, randomised, double-blind, controlled trial

WSWeihai ShiNanjing Drum Tower Hospital SZShouqiang ZhuChina Pharmaceutical University TXTianjiao XiaNanjing Medical University

Key Points

To evaluate the effect of dexmedetomidine nasal spray on postoperative sleep disturbance in laparoscopic cholecystectomy patients.
Multicentre, prospective, randomised, double-blind, controlled trial
At least 260 patients will be enrolled and randomly allocated to receive dexmedetomidine or placebo
Primary outcome is incidence of postoperative sleep disturbance measured by NRS or Athens Insomnia Scale
Evaluated effect on incidence of postoperative sleep disturbance
Assessed quality of recovery, anxiety, depression, and pain scores
Compared outcomes using statistical tests like χ2 or Fisher’s exact test

Abstract

Background Postoperative sleep disturbance (PSD) is a common complication following laparoscopic cholecystectomy (LC). It is associated with delirium, cognitive decline and delayed recovery. Effective preventive strategies are currently lacking. Dexmedetomidine, a highly selective α₂-adrenergic receptor agonist, offered in a nasal spray formulation with high bioavailability and convenient administration, may present a novel approach for PSD prevention. Objectives The primary objective is to evaluate the effect of evening dexmedetomidine nasal spray on the incidence of PSD on the first postoperative day in LC patients. Secondary objectives include assessing its impact on the quality of recovery, anxiety and depression and pain scores. Methods and analysis This is a multicentre, prospective, randomised, double-blind, controlled trial. At least 260 patients will be enrolled and randomly allocated in a 1:1 ratio to receive either dexmedetomidine (50 µg nasal spray) or saline placebo the night before and the night of surgery (between 20:00 and 22:00). The primary outcome is the incidence of PSD on postoperative day 1 defined as an Numerical Rating Scale (NRS) >6 or Athens Insomnia Scale >6 score, which will be compared between groups using the χ 2 or Fisher’s exact test on the full analysis set. Secondary outcomes include quality of recovery (Quality of Recovery-15 scale, QoR-15), anxiety and depression (Hospital Anxiety and Depression Scale, HADS), pain (NRS), postoperative nausea and vomiting and adverse events, analysed using t-tests, rank-sum tests or repeated-measures mixed-effects models as appropriate. Ethics and dissemination The study protocol has been approved by the Ethics Committee of the Affiliated Drum Tower Hospital of Nanjing University Medical School (Approval No.: 2025–0064-02) and registered with the Chinese Clinical Trial Registry. The findings of this study will be disseminated through various channels. Academic dissemination will include publication in peer-reviewed journals and presentations at national and international conferences. Trial registration number ChiCTR2500101205.

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