Effect of Remimazolam on Postoperative Delirium

Study Overview
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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.

Official Title
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Effect of General Anesthesia With Remimazolam Versus Propofol on Postoperative Delirium in Elderly Patients

Conditions
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General Anesthetic Drug Adverse Reaction

Intervention / Treatment
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* Drug: remimazolam
* Drug: propofol


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: remimazolam<br>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 | Drug: remimazolam<br>* continuous infusion<br>|
| Active Comparator: propofol<br>propofol continuous infusion is used for general anesthesia; dosage:4-8mg/kg/h; duration: from start of anesthesia induction to end of surgery | Drug: propofol<br>* continuous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 in-hospital delirium after surgery |  | from end of surgery to discharge from hospital, in an average of 5 days | 
| time to awake |  | 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 | 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 | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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general anesthesia, elderly patients, remimazolam, propofol