Effect of Remimazolam on Postoperative Delirium

Zhihong LU190 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

190

Conditions

General Anesthetic Drug Adverse Reaction

Interventions

remimazolamDRUG

continuous infusion

propofolDRUG

continuous infusion

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Xijing hospital, Fourth military medical university

Xi'an, Shaanxi, China

RECRUITING

Outcomes

Primary Outcomes

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

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

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

incidence of in-hospital delirium after surgery

Time frame: from end of surgery to discharge from hospital, in an average of 5 days

time to awake

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

incidence of hypotension during surgery

hypotension is defined as systolic blood pressure decreasing by more than 20% of baseline value

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

incidence of hypertension during surgery

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

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

level of tumor necrosis factor α at the end of the surgery

Time frame: at the end of the surgery

level of serum S100β at the end of the surgery

Central Contacts

Zhihong Lu

CONTACT

+8613891975018 deerlu23@163.com

Data from ClinicalTrials.gov

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