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

Study Overview

This study compares the effects of two sedatives, remimazolam tosilate and sevoflurane, on the occurrence of postoperative delirium (POD) in older patients undergoing total hip surgery.

Why This Study Matters

Postoperative delirium is a common issue after surgery, especially in older adults. It can lead to serious complications. Understanding which sedative may reduce the risk of POD is crucial for improving patient care.

Study Details

  • Participants: 456 older patients from six hospitals in China.
  • Method: Patients will be randomly assigned to receive either remimazolam tosilate or sevoflurane during surgery.
  • Primary Goal: Measure the rate of POD in the first four days after surgery.
  • Secondary Goals: Assess cognitive function, pain levels, nausea and vomiting, recovery time, medication use, hospital stay duration, and complications.

Ethics and Approval

The study has received ethical approval and will ensure informed consent from all participants. Results will be shared in a medical journal.

Trial Registration

This trial is registered with the Chinese Clinical Trial Registry.

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