Remimazolam and Endovascular Procedures of Cerebrovascular Diseases

NCT04950621 | Completed

• 1 other identifier: XJH-A-20201225
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Disorders; Anesthesia

Keywords

propofol; Remimazolam; Endovascular Procedures

Outcome Measures

Primary Outcomes (1)

• time to open eye

  from the stop of trial drugs to open eye to verbal command, at an average of 15 minutes

Secondary Outcomes (16)

• 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

Study Arms (2)

Remimazolam

EXPERIMENTAL

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

Propofol

ACTIVE COMPARATOR

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

Interventions

remimazolam DRUG

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

Remimazolam

propofol DRUG

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

Propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 years or older
• scheduled for interventional neurosurgery of cerebrovascular disorders under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (3)

• Sneyd JR, Rigby-Jones AE. Remimazolam for anaesthesia or sedation. Curr Opin Anaesthesiol. 2020 Aug;33(4):506-511. doi: 10.1097/ACO.0000000000000877.

  PMID: 32530890 RESULT

• Keam SJ. Remimazolam: First Approval. Drugs. 2020 Apr;80(6):625-633. doi: 10.1007/s40265-020-01299-8.

  PMID: 32274703 RESULT

• Pastis NJ, Yarmus LB, Schippers F, Ostroff R, Chen A, Akulian J, Wahidi M, Shojaee S, Tanner NT, Callahan SP, Feldman G, Lorch DG Jr, Ndukwu I, Pritchett MA, Silvestri GA; PAION Investigators. Safety and Efficacy of Remimazolam Compared With Placebo and Midazolam for Moderate Sedation During Bronchoscopy. Chest. 2019 Jan;155(1):137-146. doi: 10.1016/j.chest.2018.09.015. Epub 2018 Oct 4.

  PMID: 30292760 RESULT

MeSH Terms

Conditions

Cerebrovascular Disorders

Interventions

remimazolam; Propofol

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 6, 2021
• Study Start: July 13, 2021
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

CN (1)