A comprehensive evaluation between dexmedetomidine and midazolam for intraoperative sedation in the elderly: protocol for a systematic review and meta-analysis of randomized controlled trials

BACKGROUND: The sedative effect of intraoperative sedation in elderly surgery exerts critical influence on the prognosis. Comparison on the safety and efficacy between dexmedetomidine and midazolam in many clinical randomized controlled trials (RCTs) was inconsistent and suspicious. We aim to comprehensively evaluate the safety and efficacy between dexmedetomidine and midazolam for intraoperative sedation in the elderly via meta-analysis and systematic reviews. METHODS: RCTs regarding to the comparison of sedative effects and safety between dexmedetomidine and midazolam in elderly patients (aged ≥ 60 years) will be comprehensively searched from 2000 October to 2022 May through 4 English databases and 4 Chinese databases. After extraction in duplicate, the systematic review and meta-analysis will be performed on the primary outcomes (hemodynamic changes, sedative effect, cognitive function) and secondary outcomes (analgesic effect, surgical characteristics, complications, or adverse reactions) for assessing the two therapy methods using Review Manager software (Version 5.3). Sensitivity analysis will be conducted to evaluate the heterogeneity of the results; funnel plot and Egger’s trial will be performed to analyze publication bias of the included studies, and trial sequential analysis will be applied to assess the robustness and reliability of preliminary meta-analysis results. Finally, rating quality of evidence and strength of recommendations on the meta results will be summarized by Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. DISCUSSION: This systematic review and meta-analysis will evaluate the safety and efficacy between dexmedetomidine and midazolam for intraoperative sedation in the elderly; it will give an insight on the application of dexmedetomidine and midazolam and will provide evidence-based reference for clinical decision-making. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021221897