Effect of remimazolam tosilate for injection (HR7056) versus sevoflurane on the incidence of postoperative delirium in older patients undergoing total hip arthroplasty: study protocol for a prospective, multicentre, two-arm, parallel-group, randomised controlled trial

Feb 18, 2025BMC geriatrics

Remimazolam versus sevoflurane and the risk of confusion after hip replacement in older patients

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Abstract

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.

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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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Effect of remimazolam tosilate for injection (HR7056) versus sevoflurane on the incidence of postoperative delirium in older patients undergoing total hip arthroplasty: study protocol for a prospective, multicentre, two-arm, parallel-group, randomised controlled trial

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