Remimazolam and Endovascular Procedures of Cerebrovascular Diseases

Not Applicable

Completed

• Conditions: Cerebrovascular Disorders; Anesthesia
• Interventions: Drug: remimazolam; Drug: propofol

• Registration Number: NCT04950621
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-27
• Study First Submitted QC: 2021-06-27
• Study First Posted: 2021-07-06
• Study Start: 2021-07-13
• Primary Completion: 2022-06-30
• Study Completion: 2022-09-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam	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.
Propofol	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 orientation	from end of giving trial drugs to recovery of orientation to name, location or date ,at an average of 30 minutes
The highest Richmond Agitation and Sedation Score during emergence	from end of the surgery to 30 minutes after extubation, approximately 50 minutes
the level of serum interleukin-6, tumor necrosis factor-α and S100β	at the end of the surgery
time to recovery of spontaneous breathing	from end of giving trial drugs to recovery of spontaneous breathing ,at an average of 20 minutes
the level of lactic acid of arterial blood	at the end of the surgery
Renkin's Score at 30 days and three months after surgery	30 days and three months 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
time to endotracheal tube extubation	from end of giving trial drugs to removing endotracheal tube ,at an average of 25 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	from initial administration of trial drugs to end of surgery, at an average of 3 hours	Hypotension is defined as decrease of mean arterial pressure more than 20% of the baseline, persisting longer than 1 minute
Number of episodes of hypertension during surgery	from initial administration of trial drugs to end of surgery, at an average of 3 hours	Hypertension is defined as increase of mean arterial pressure more than 20% of the baseline, persisting longer than 1 minute
Glasgow outcome Score at discharge	at discharge, approximately 3 days after surgery
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

Trial Locations

Locations (1)

Xijing hospital; 🇨🇳 Xi'an, Shaanxi, China