Remimazolam and Endovascular Procedures of Cerebrovascular Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-13

Study Completion Date

2022-09-30

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.

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Detailed Description

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Conditions

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Cerebrovascular Disorders Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Randomization is done by an investigator who is not involved in anesthesia and outcome assessment. Participants are unaware of the group allocation. Due to the different color of remimazolam and propofol, the care provider is not blinded to the group allocation. At the end of the surgery, anesthetics are removed before outcome assessment. And the outcome assessor is blinded to the grouping.

Study Groups

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Remimazolam

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.

Group Type EXPERIMENTAL

remimazolam

Intervention Type DRUG

Remimazolam will be administered during induction and maintenance for general anesthesia.

Propofol

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.

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

Propofol will be administered during induction and maintenance for general anesthesia.

Interventions

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remimazolam

Remimazolam will be administered during induction and maintenance for general anesthesia.

Intervention Type DRUG

propofol

Propofol will be administered during induction and maintenance for general anesthesia.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. aged 18 years or older
2. scheduled for interventional neurosurgery of cerebrovascular disorders under general anesthesia

Exclusion Criteria

1. American Society of Anesthesiologists class Ⅲ or higher
2. Hunt-Hess class Ⅲ or higher
3. body mass index (BMI) \< 18 kg/㎡ or \> 30kg/㎡
4. large or giant cerebral aneurysms with diameters greater than 15mm and minor cerebral aneurysms with diameters less than 3mm
5. posterior circulation infarction
6. recurrence of an cerebral aneurysms after endovascular procedures or surgical clipping
7. severe abnormal coagulation function, severe liver and kidney function damage, or combined with heart and respiratory system failure
8. be allergic or likely to be allergic to the study drugs
9. participate in other clinical researchers within 3 months
10. history of neurological or psychiatric diseases
11. existed or suspected abuse of drug or alcohol
12. use of sedative or analgesics before surgery
13. patients with difficulty in communication

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No