Effect of Remimazolam on Postoperative Delirium

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-25

Study Completion Date

2024-01-30

Brief Summary

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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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Detailed Description

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Conditions

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General Anesthetic Drug Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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remimazolam

remimazolam continuous infusion is used for general anesthesia; dosage:0.7-1.5mg/kg/h; duration: from start of anesthesia induction to end of surgery

Group Type EXPERIMENTAL

remimazolam

Intervention Type DRUG

continuous infusion

propofol

propofol continuous infusion is used for general anesthesia; dosage:4-8mg/kg/h; duration: from start of anesthesia induction to end of surgery

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

continuous infusion

Interventions

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remimazolam

continuous infusion

Intervention Type DRUG

propofol

continuous infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥65 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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No