Remimazolam and Endovascular Procedures of Cerebrovascular Diseases

Study Overview
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Brief Summary
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Remimazolam, a novel ultra-short acting benzodiazepine that combined the advantages of midazolam and remifentanil, has been developed for procedural sedation, induction and maintenance of general anesthesia, and sedation in the ICU. Previous studies have suggested that efficacy and safety of remimazolam are not inferior to propofol or midazolam in patients undergoing colonoscopy,bronchoscopy and some other treatments. However, the efficacy and potential adverse effects of remimazolam on patients undergoing endovascular procedures of cerebrovascular disorders is still unclear. In this study, we tend to conduct a single-center, randomized, single-blind ,non-inferiority trial to compare the efficacy and safety of remimazolam and propofol in endovascular procedures of cerebrovascular disorders.

Official Title
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Comparison of Efficacy and Safety of Remimazolam and Propofol in Patients Undergoing Endovascular Procedures of Cerebrovascular Disorders: A Single-center,Randomized,Single-blind, Non-inferiority Trial

Conditions
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Cerebrovascular Disorders, Anesthesia

Intervention / Treatment
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* Drug: remimazolam
* Drug: propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18 years or older scheduled for interventional neurosurgery of cerebrovascular disorders under general anesthesia Exclusion Criteria: American Society of Anesthesiologists class Ⅲ or higher Hunt-Hess class Ⅲ or higher body mass index (BMI) < 18 kg/㎡ or > 30kg/㎡ large or giant cerebral aneurysms with diameters greater than 15mm and minor cerebral aneurysms with diameters less than 3mm posterior circulation infarction recurrence of an cerebral aneurysms after endovascular procedures or surgical clipping severe abnormal coagulation function, severe liver and kidney function damage, or combined with heart and respiratory system failure be allergic or likely to be allergic to the study drugs participate in other clinical researchers within 3 months history of neurological or psychiatric diseases existed or suspected abuse of drug or alcohol use of sedative or analgesics before surgery patients with difficulty in communication

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam<br>In remimazolam group, a 0.1 mg/kg dose of intravenous remimazolam was administered for induction, and 0.3-0.7 mg/kg/h infusion for maintenance after intubation. | Drug: remimazolam<br>* Remimazolam will be administered during induction and maintenance for general anesthesia.<br>|
| Active Comparator: Propofol<br>In propofol group, a 2 mg/kg dose of intravenous propofol was administered for induction, and 4-12 mg/kg/h infusion for maintenance after intubation. | Drug: propofol<br>* Propofol will be administered during induction and maintenance for general anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to open eye |  | from the stop of trial drugs to open eye to verbal command, at an average of 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to loss of consciousness |  | from initial administration of trial drugs to loss of response to verbal command, at an average of 5 minutes | 
| time to recovery of spontaneous breathing |  | from end of giving trial drugs to recovery of spontaneous breathing ,at an average of 20 minutes | 
| time to endotracheal tube extubation |  | from end of giving trial drugs to removing endotracheal tube ,at an average of 25 minutes | 
| time to orientation |  | from end of giving trial drugs to recovery of orientation to name, location or date ,at an average of 30 minutes | 
| the dosages of vasoactive drugs during surgery |  | from initial administration of trial drugs to end of surgery, at an average of 3 hours | 
| Number of episodes of hypotension during surgery | Hypotension is defined as decrease of mean arterial pressure more than 20% of the baseline, persisting longer than 1 minute | from initial administration of trial drugs to end of surgery, at an average of 3 hours | 
| Number of episodes of hypertension during surgery | Hypertension is defined as increase of mean arterial pressure more than 20% of the baseline, persisting longer than 1 minute | from initial administration of trial drugs to end of surgery, at an average of 3 hours | 
| the level of lactic acid of arterial blood |  | at the end of the surgery | 
| The highest Richmond Agitation and Sedation Score during emergence |  | from end of the surgery to 30 minutes after extubation, approximately 50 minutes | 
| Renkin's Score at 30 days and three months after surgery |  | 30 days and three months after surgery | 
| Glasgow outcome Score at discharge |  | at discharge, approximately 3 days after surgery | 
| length of postoperative ICU stay and hospital stay |  | from entering the ICU to leaving the ICU and from admission to discharge, approximately 3 days | 
| the incidence of major complications during postoperative hospitalization |  | from the end of surgery to discharge, approximately 3 days | 
| the incidence of delirium during emergence |  | from end of surgery to 30 minutes after extubation | 
| the incidence of delirium within 3 days after surgery |  | from end of surgery to 3 days after surgery | 
| the level of serum interleukin-6, tumor necrosis factor-α and S100β |  | 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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propofol, Remimazolam, Endovascular Procedures