Effect of Remimazolam on Postoperative Delirium (RED)

August 8, 2026 updated by: Zhihong LU

Effect of General Anesthesia With Remimazolam Versus Propofol on Postoperative Delirium in Elderly Patients

Remimazolam is a novel benzodiazepine with ultra-short onset and offset of its effect. It can be used for general anesthesia. However, classical benzodiazepine such as midazolam was reported to increase the risk of postoperative delirium. Thus, the investigators aim to investigate the effect of remimazolam general anesthesia on postoperative delirium in elderly patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

262

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing hospital, Fourth military medical university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥60 years
  • patients scheduled for elective surgery under general anesthesia

Exclusion Criteria:

  • American Society of Anesthesiologists status ≥Ⅳ
  • history of neurologic or psychiatric diseases
  • difficulty in communication
  • abuse of drug or alcohol
  • suspected allergy to propofol or benzodiazepines
  • significant cardiac, pulmonary, hepatic, or renal dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: remimazolam
Remimazolam (0.15 mg/kg) is used for anesthesia induction. Remimazolam continuous infusion is used for general anesthesia maintenance; dosage:0.7-1.5mg/kg/h; duration: from start of anesthesia induction to end of surgery
Drug: remimazolam
continuous infusion
Active Comparator: propofol
Propofol (1.5 mg/kg) is used for anesthesia induction. Propofol continuous infusion is used for general anesthesia maintenance; dosage:4-8mg/kg/h; duration: from start of anesthesia induction to end of surgery
Drug: propofol
continuous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of delirium by 3 days after surgery
Time Frame: from end of surgery to 3 days after surgery, in a total of 3 days
from end of surgery to 3 days after surgery, in a total of 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of delirium by 1 day after surgery
Time Frame: from end of surgery to 1 day after surgery, in a total of 1 day
from end of surgery to 1 day after surgery, in a total of 1 day
incidence of hypotension during surgery
Time Frame: from start of anesthesia induction to extubation, in an average of 2 hours
hypotension is defined as systolic blood pressure decreasing by more than 20% of baseline value
from start of anesthesia induction to extubation, in an average of 2 hours
Duration of sleep on the first night after surgery
Time Frame: from end of surgery to 24 hours after surgery, in a total of 24 hours
sleep is monitored by a wrist acti-graphy
from end of surgery to 24 hours after surgery, in a total of 24 hours
incidence of delirium by 30 minutes after extubation (emergence delirium)
Time Frame: from extubation of tracheal tube to 30 minutes after extubation, in a total of 30 minutes
from extubation of tracheal tube to 30 minutes after extubation, in a total of 30 minutes
time to eye opening
Time Frame: from end of surgery to open eye response to verbal command, in an average of 10 minutes
from end of surgery to open eye response to verbal command, in an average of 10 minutes
time to orientation
Time Frame: from end of surgery to being able to speak out name in an average of 10 minutes
from end of surgery to being able to speak out name in an average of 10 minutes
dosage of vasoactive drugs during surgery
Time Frame: from start of anesthesia induction to extubation, in an average of 2 hours
vasoactive drugs refer to norepinephrine and epinephrine
from start of anesthesia induction to extubation, in an average of 2 hours
the visual analogue scale of sleep on the next day after surgery
Time Frame: from end of surgery to 24 hours after surgery, in a total of 24 hours
0 is the worst quality of sleep, 10 is the best quality of sleep
from end of surgery to 24 hours after surgery, in a total of 24 hours
the Athens Insomnia scale (AIS) of sleep on the next day after surgery
Time Frame: from end of surgery to 24 hours after surgery, in a total of 24 hours
The AIS is a self-reported questionnaire designed to quantify sleep difficulty based on ICD-10 diagnostic criteria. It consists of 8 items rated on a 4-point scale (0 = no problem, 3 = severe problem), yielding a total score ranging from 0 to 24. A cutoff score of 6 provides optimal sensitivity and specificity for screening insomnia.
from end of surgery to 24 hours after surgery, in a total of 24 hours
the time to onset of delirium
Time Frame: from end of surgery to onset of delirium, in an average of 1 days
from end of surgery to onset of delirium, in an average of 1 days
the duration of delirium
Time Frame: from onset of delirium to the last day of delirium, in an average of 3 days
the time between the first and last delirium-positive days
from onset of delirium to the last day of delirium, in an average of 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhihong LU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2022

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

June 28, 2022

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Actual)

December 26, 2023

Study Record Updates

Last Update Posted (Actual)

August 12, 2026

Last Update Submitted That Met QC Criteria

August 8, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJH-A-20220628

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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