Effect of Remimazolam on Postoperative Delirium

Not Applicable

Recruiting

• Conditions: General Anesthetic Drug Adverse Reaction
• Interventions: Drug: remimazolam; Drug: propofol

• Registration Number: NCT06180876
• Lead Sponsor: Zhihong LU

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-25
• Study First Submitted: 2022-06-28
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-12
• Last Update Submitted: 2023-12-12
• Study First Posted: 2023-12-26
• Last Update Posted: 2023-12-26
• Primary Completion: 2024-01-25
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
incidence of delirium by 3 days after surgery	from end of surgery to 3 days after surgery, in a total of 3 days

Secondary Outcome Measures

Name	Time	Method
incidence of hypotension during surgery	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
incidence of in-hospital delirium after surgery	from end of surgery to discharge from hospital, in an average of 5 days
level of tumor necrosis factor α at the end of the surgery	at the end of the surgery
level of serum S100β at the end of the surgery	at the end of the surgery
level of interleukin α at the end of the surgery	at the end of the surgery
incidence of delirium by 30 minutes after extubation	from extubation of tracheal tube to 30 minutes after extubation, in a total of 30 minutes
incidence of delirium by 1 day after surgery	from end of surgery to 1 day after surgery, in a total of 1 day
incidence of hypertension during surgery	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
time to awake	from end of surgery to response to verbal command, in an average of 10 minutes

Trial Locations

Locations (1)

Xijing hospital, Fourth military medical university; 🇨🇳 Xi'an, Shaanxi, China