Effect of Remimazolam on Postoperative Delirium (RED)

Zhihong LU

Status: Enrolling

Conditions: General Anesthetic Drug Adverse Reaction

Treatments: Drug: propofol; Drug: remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT06180876

XJH-A-20220628

Details and patient eligibility

About

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.

Enrollment: 190 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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190 participants in 2 patient groups

remimazolam

Experimental group

Description:

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

Treatment:

Drug: remimazolam

propofol

Active Comparator group

Description:

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

Treatment:

Drug: propofol