Comparison of Remimazolam and Propofol Combination vs. Propofol in IOM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-31

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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This study hypothesizes that the combination regimen of remimazolam and propofol as total intravenous anesthesia in neurosurgical procedures requiring neurophysiological monitoring can reduce the incidence of hypotension compared to propofol monotherapy while providing comparable levels of neurophysiological monitoring and surgical conditions. With this hypothesis, the study aims to compare the frequency, severity, and duration of hypotension, frequency of patient movement, and appropriateness of neurophysiological monitoring between the combination therapy of remimazolam and propofol and propofol monotherapy in total intravenous anesthesia.

Conditions

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Neurologic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Combination group

Combination regimen (remimazolam plus propofol)

Group Type EXPERIMENTAL

Remimazolam besylate + propofol MCT

Intervention Type DRUG

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

Propofol group

Propofol monotherapy

Group Type ACTIVE_COMPARATOR

Propofol MCT

Intervention Type DRUG

Propofol MCT 2-8 mcg/ml using target-controlled infusion

Interventions

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Remimazolam besylate + propofol MCT

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

Intervention Type DRUG

Propofol MCT

Propofol MCT 2-8 mcg/ml using target-controlled infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

1. Patients who refuse to participate in the study.
2. Patients who are pregnant or lactating.
3. Patients with hypersensitivity to the investigational drugs or to soy, peanuts, or Dextran 40.
4. Patients with acute narrow-angle glaucoma.
5. Patients with alcohol or drug dependence.
6. Patients with hepatic impairment classified as Child-Pugh class C.
7. Patients with lactose intolerance.
8. Patients requiring emergency surgery.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No