Comparison of Remimazolam and Propofol Combination vs. Propofol in IOM

Phase 4Not Yet RecruitingNCT06382467

Chung-Ang University Gwangmyeong Hospital56 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Neurologic Disorder

Interventions

Remimazolam besylate + propofol MCTDRUG

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 MCTDRUG

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

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.