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Completed

NCT Number: NCT06180876

Effect of Remimazolam on Postoperative Delirium

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.

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Key information

Conditions

General Anesthetic Drug Adverse Reaction

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing hospital, Fourth military medical university

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam

Drug

continuous infusion

Propofol

Drug

continuous infusion

Primary outcomes

  1. 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

Secondary outcomes

  1. incidence of delirium by 30 minutes after extubation

    Time frame: from extubation of tracheal tube to 30 minutes after extubation, in a total of 30 minutes

  2. 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

  3. time to awake

    Time frame: from end of surgery to response to verbal command, in an average of 10 minutes

  4. 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

  5. incidence of hypertension during surgery

    Time frame: from start of anesthesia induction to extubation, in an average of 2 hours

    hypertension is defined as systolic blood pressure increasing by more than 20% of baseline value

  6. 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

Sponsors and collaborators

Lead sponsor

Zhihong LU

Other

Registry information

Official study title

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

Acronym: RED

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 26, 2023
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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