Intranasal dexmedetomidine for perioperative sleep disturbance: a protocol for a systematic review with meta-analysis and trial sequential analysis.
Dan Liu, Yujie Huang, Li Du, Weiyi Zhang, Tingting Li, Jianqiao Zheng
Abstract
Open AccessINTRODUCTION: Perioperative sleep disturbance (PSD) can adversely affect immunological and cognitive functions, can prolong hospital stays and have long-lasting effects on quality of life, ultimately increasing mortality rates. Unfortunately, PSD is common among surgical patients and can manifest at any stage during surgical care with a high incidence. Owing to the high incidence and severe adverse outcomes of PSD, effective management of PSD is imperative in clinical practice. Intranasal administration of dexmedetomidine is a safe and effective strategy for improving perioperative sleep quality. It is characterised by high bioavailability, a low incidence of adverse events and the avoidance of pain from venipuncture and intramuscular injection. However, this clinical evidence is insufficient due to the limited sample size, diverse outcome observation indicators and inconsistent research quality. Consequently, we will conduct a protocol for a systematic review and meta-analysis to offer clinical evidence on whether intranasal dexmedetomidine can be opted as an effective treatment for PSD. METHODS AND ANALYSIS: English databases (PubMed, Web of Science, Ovid Medline, Embase and Cochrane Library), Chinese electronic databases (Wanfang database, VIP Database and China National Knowledge Infrastructure) and clinical trial registry platforms will be screened from their inception up to October 2025 to detect randomised controlled trials of intranasal dexmedetomidine for the management of PSD. We will compute the mean differences (MDs) or standardised MDs along with 95% CIs for continuous data, and the risk ratio with 95% CIs for dichotomous data using Review Manager V.5.4. Either the fixed-effects or random-effects model will be employed depending on the heterogeneity assessed by Cochran's Q test and the I2 statistic. Risk of bias will be assessed by Cochrane risk-of-bias tool V.2, while evidence quality will be evaluated by the Grading of Recommendations Assessment, Development and Evaluation approach. The conclusiveness of evidence will be evaluated via trial sequential analysis. Moreover, publication bias will be assessed via funnel plot analysis supplemented with Egger's regression test. ETHICS AND DISSEMINATION: Ethical approval was not required for this systematic review protocol. The results will be disseminated through peer-reviewed publications. PROSPERO REGISTRATION NUMBER: CRD420251002119.