Clinical trial NCT06382467: Comparison of Remimazolam and Propofol Combination vs. Propofol in IOM
Official title: Comparison of Remimazolam and Propofol Combination vs. Propofol in Intraoperative Neurophysiologic Monitoring: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Neurologic Disorder
Lead sponsor: Chung-Ang University Gwangmyeong Hospital
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of intraoperative hypotension
timeFrame: operation day - postoperative 1 day
Secondary outcomes:
measure: Amount and number of inotropic agents
timeFrame: operation day - postoperative 1 day
measure: Incidence of participants' intraoperative involuntary movement
timeFrame: operation day - postoperative 1 day
measure: scores of neurophysiologic monitoring quality
timeFrame: operation day - postoperative 1 day
measure: onset time of study drugs
timeFrame: operation day - postoperative 1 day
measure: The administration number of rescue anti-emetic agents
timeFrame: operation day - postoperative 3 day
measure: Time-weighted average of intraoperative hypotension
timeFrame: operation day - postoperative 1 day
measure: recovery time of study drugs (remimazolam+propofol or propofol)
timeFrame: operation day - postoperative 1 day
Other outcomes:
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