Back to resultsRemimazolam and Endovascular Procedures of Cerebrovascular Diseases (REPEAT)
Primary Purpose
Cerebrovascular Disorders, Anesthesia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
remimazolam
propofol
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Disorders focused on measuring propofol, Remimazolam, Endovascular Procedures
Eligibility Criteria
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
Sites / Locations
- Xijing hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Remimazolam
Propofol
Arm 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.
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.
Outcomes
Primary Outcome Measures
time to open eye
Secondary Outcome Measures
time to loss of consciousness
time to recovery of spontaneous breathing
time to endotracheal tube extubation
time to orientation
the dosages of vasoactive drugs during surgery
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
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
the level of lactic acid of arterial blood
The highest Richmond Agitation and Sedation Score during emergence
Renkin's Score at 30 days and three months after surgery
Glasgow outcome Score at discharge
length of postoperative ICU stay and hospital stay
the incidence of major complications during postoperative hospitalization
the incidence of delirium during emergence
the incidence of delirium within 3 days after surgery
the level of serum interleukin-6, tumor necrosis factor-α and S100β
Full Information
NCT ID
NCT04950621
First Posted
June 27, 2021
Last Updated
October 19, 2022
Sponsor
Air Force Military Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT04950621
Brief Title
Remimazolam and Endovascular Procedures of Cerebrovascular Diseases
Acronym
REPEAT
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 13, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disorders, Anesthesia
Keywords
propofol, Remimazolam, Endovascular Procedures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remimazolam
Arm Type
Experimental
Arm 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.
Arm Title
Propofol
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
remimazolam
Intervention Description
Remimazolam will be administered during induction and maintenance for general anesthesia.
Intervention Type
Drug
Intervention Name(s)
propofol
Intervention Description
Propofol will be administered during induction and maintenance for general anesthesia.
Primary Outcome Measure Information:
Title
time to open eye
Time Frame
from the stop of trial drugs to open eye to verbal command, at an average of 15 minutes
Secondary Outcome Measure Information:
Title
time to loss of consciousness
Time Frame
from initial administration of trial drugs to loss of response to verbal command, at an average of 5 minutes
Title
time to recovery of spontaneous breathing
Time Frame
from end of giving trial drugs to recovery of spontaneous breathing ,at an average of 20 minutes
Title
time to endotracheal tube extubation
Time Frame
from end of giving trial drugs to removing endotracheal tube ,at an average of 25 minutes
Title
time to orientation
Time Frame
from end of giving trial drugs to recovery of orientation to name, location or date ,at an average of 30 minutes
Title
the dosages of vasoactive drugs during surgery
Time Frame
from initial administration of trial drugs to end of surgery, at an average of 3 hours
Title
Number of episodes of hypotension during surgery
Description
Hypotension is defined as decrease of mean arterial pressure more than 20% of the baseline, persisting longer than 1 minute
Time Frame
from initial administration of trial drugs to end of surgery, at an average of 3 hours
Title
Number of episodes of hypertension during surgery
Description
Hypertension is defined as increase of mean arterial pressure more than 20% of the baseline, persisting longer than 1 minute
Time Frame
from initial administration of trial drugs to end of surgery, at an average of 3 hours
Title
the level of lactic acid of arterial blood
Time Frame
at the end of the surgery
Title
The highest Richmond Agitation and Sedation Score during emergence
Time Frame
from end of the surgery to 30 minutes after extubation, approximately 50 minutes
Title
Renkin's Score at 30 days and three months after surgery
Time Frame
30 days and three months after surgery
Title
Glasgow outcome Score at discharge
Time Frame
at discharge, approximately 3 days after surgery
Title
length of postoperative ICU stay and hospital stay
Time Frame
from entering the ICU to leaving the ICU and from admission to discharge, approximately 3 days
Title
the incidence of major complications during postoperative hospitalization
Time Frame
from the end of surgery to discharge, approximately 3 days
Title
the incidence of delirium during emergence
Time Frame
from end of surgery to 30 minutes after extubation
Title
the incidence of delirium within 3 days after surgery
Time Frame
from end of surgery to 3 days after surgery
Title
the level of serum interleukin-6, tumor necrosis factor-α and S100β
Time Frame
at the end of the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Xijing hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
individual data including protocol and statistical analysis plan will be shared during 3 months and 5 years following article publication after deidentification
Citations:
PubMed Identifier
32530890
Citation
Sneyd JR, Rigby-Jones AE. Remimazolam for anaesthesia or sedation. Curr Opin Anaesthesiol. 2020 Aug;33(4):506-511. doi: 10.1097/ACO.0000000000000877.
Results Reference
result
PubMed Identifier
32274703
Citation
Keam SJ. Remimazolam: First Approval. Drugs. 2020 Apr;80(6):625-633. doi: 10.1007/s40265-020-01299-8.
Results Reference
result
PubMed Identifier
30292760
Citation
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.
Results Reference
result
Learn more about this trial
Remimazolam and Endovascular Procedures of Cerebrovascular Diseases
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