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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
  • significant cardiac, pulmonary, hepatic, or renal dysfunction

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 (emergence delirium)

    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 eye opening

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

  4. time to orientation

    Time frame: from end of surgery to being able to speak out name in an average of 10 minutes

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  10. the time to onset of delirium

    Time frame: from end of surgery to onset of delirium, in an average of 1 days

  11. 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

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
Aug 12, 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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