Comparison of Remimazolam and Propofol Combination vs. Propofol in IOM
1 other identifier
interventional
56
0 countries
N/A
Brief Summary
This study aims to compare total intravenous anesthetic agents: combined remimazolam and propofol vs. propofol monotherapy. The comparison parameters are intraoperative hypotension, patient's involuntary movement, neurophysiological monitoring quality, onset time, recovery time, and postoperative rescue anti-emetics requirements.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2024
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2024
CompletedFirst Posted
Study publicly available on registry
April 24, 2024
CompletedStudy Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedApril 24, 2024
April 1, 2024
1 year
April 17, 2024
April 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of intraoperative hypotension
mean arterial pressure \< 65mmHg
operation day - postoperative 1 day
Secondary Outcomes (7)
Amount and number of inotropic agents
operation day - postoperative 1 day
Incidence of participants' intraoperative involuntary movement
operation day - postoperative 1 day
scores of neurophysiologic monitoring quality
operation day - postoperative 1 day
onset time of study drugs
operation day - postoperative 1 day
The administration number of rescue anti-emetic agents
operation day - postoperative 3 day
- +2 more secondary outcomes
Study Arms (2)
Combination group
EXPERIMENTALCombination regimen (remimazolam plus propofol)
Propofol group
ACTIVE COMPARATORPropofol monotherapy
Interventions
remimazolam besylate 3mg/kg/hr for induction, and 0.5 mg/kg/hr for maintenance + propofol MCT 1-4 mcg/ml using target-controlled infusion
Eligibility Criteria
You may qualify if:
- Patients aged 19 and above with planned neurosurgical procedures requiring neurophysiological monitoring, classified as American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3 in the United States.
You may not qualify if:
- Patients who refuse to participate in the study.
- Patients who are pregnant or lactating.
- Patients with hypersensitivity to the investigational drugs or to soy, peanuts, or Dextran 40.
- Patients with acute narrow-angle glaucoma.
- Patients with alcohol or drug dependence.
- Patients with hepatic impairment classified as Child-Pugh class C.
- Patients with lactose intolerance.
- Patients requiring emergency surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
April 17, 2024
First Posted
April 24, 2024
Study Start
May 1, 2024
Primary Completion
May 1, 2025
Study Completion
June 1, 2025
Last Updated
April 24, 2024
Record last verified: 2024-04