A total of 456 older patients will be evaluated for the incidence of (POD) after receiving either remimazolam tosilate or sevoflurane during total hip arthroplasty.
Postoperative delirium is a common complication associated with adverse outcomes following surgery.
Advanced age and hip surgery are identified as significant risk factors for developing POD.
The primary outcome will assess the prevalence of POD during the first 4 postoperative days.
Secondary outcomes include cognitive function, pain levels, postoperative nausea and vomiting, recovery time, and length of hospital stay.
Simplified
INTRODUCTION: (POD) is a common postoperative complication and is associated with numerous adverse outcomes. Advanced age and hip surgery are high risk factors for POD. Both remimazolam tosilate for injection and sevoflurane can be used as sedatives for the maintenance of general anesthesia, but the comparison of their impacts on the incidence of POD has not been reported. This study aims to compare the effect of remimazolam tosilate vernus sevoflurane on the incidence of POD in older patients undergoing total hip arthroplasty.
METHODS AND ANALYSIS: This is a two-arm, parallel, prospective, multicenter, randomized controlled trial. A total of 456 older patients at six clinical trial centers in China will be randomly assigned in a 1:1 ratio to receive general anesthesia with remimazolam tosilate or sevoflurane as sedative. The primary outcome measure is the prevalence of POD during the first 4 postoperative days. Secondary outcomes include cognitive function [Mini-Mental State Examination (MMSE)], perioperative pain degree [Visual Analogue Scale (VAS)], postoperative nausea and vomiting (PONV) within 4 days after surgery, recovery time after drug withdrawal, the amount of vasoactive drugs used during operation, length of hospital stay, and in-hospital complications.
ETHICS AND DISSEMINATION: The Research Ethics Committee of Qilu Hospital of Shandong University has approved the study protocol (REF: KYLL-202206-25), which is applicable to all research centers. Participant recruitment begins in August 2022. Written informed consent will be obtained from each patient before randomization. The findings will be published in an international peer-reviewed medical journal.
TRIAL REGISTRATION: The trial has been registered at the Chinese Clinical Trial Registry: ChiCTR2200062455; date of registration: 2022-08-08.
Key numbers
19.7%
Incidence of in sevoflurane group
Estimated incidence of based on previous studies.
9.9%
Incidence of in remimazolam tosilate group
Projected prevalence based on preliminary experiments.
456
Total participants planned
Total number of participants to be enrolled across six centers.
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Declarations. Ethics approval and consent to participate: During the study, we will strictly follow the Declaration of Helsinki and China’s good clinical practice guidelines to ensure that patients’ rights are not violated. The study protocol has been approved by the Scientific Research Ethics Committee of Qilu Hospital of Shandong University (KYLL-202206-25). This study has been registered in the Chinese Clinical Trial Registry (ChiCTR2200062455) on 8 August 2022. Written informed consent will be obtained from each patient. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.
