Remimazolam and Endovascular Procedures of Cerebrovascular Diseases (REPEAT)

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Cerebrovascular Disorders; Anesthesia

Treatments: Drug: remimazolam; Drug: propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT04950621

XJH-A-20201225

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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142 participants in 2 patient groups

Remimazolam

Experimental group

Description:

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.

Treatment:

Drug: remimazolam

Propofol

Active Comparator group

Description:

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.

Treatment:

Drug: propofol