Comparison of Remimazolam and Propofol Combination vs. Propofol in IOM
- Conditions
- Neurologic Disorder
- Interventions
- Registration Number
- NCT06382467
- Lead Sponsor
- Chung-Ang University Gwangmyeong Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 56
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combination group Remimazolam besylate + propofol MCT Combination regimen (remimazolam plus propofol) Propofol group Propofol MCT Propofol monotherapy
- Primary Outcome Measures
Name Time Method Incidence of intraoperative hypotension operation day - postoperative 1 day mean arterial pressure \< 65mmHg
- Secondary Outcome Measures
Name Time Method Amount and number of inotropic agents operation day - postoperative 1 day intraoperative inotropics amount (phenylephrine(mcg), ephedrine(mg), norepinephrine(mcg), dopamine(mg))
Incidence of participants' intraoperative involuntary movement operation day - postoperative 1 day number of patients involuntary movement during operation (ex. no movement:0 , 3 times of movement: 3)
scores of neurophysiologic monitoring quality operation day - postoperative 1 day 0-5 scale of neurophysiologic monitoring quality, scored by neurophysiologic monitoring technologist (poor: 0, good: 5)
onset time of study drugs operation day - postoperative 1 day time from administration of study drugs(remimazolam+propofol or propofol) to Bispectral index value \< 60
The administration number of rescue anti-emetic agents operation day - postoperative 3 day postoperative rescue anti-emetic agents (ramosetron, palonosetron, metoclopramide) requirements
Time-weighted average of intraoperative hypotension operation day - postoperative 1 day (depth of hypotension in millimeters of mercury below a MAP of 65mmHg × time in minutes spent below a MAP of 65mmHg)÷total duration of operation in minutes
recovery time of study drugs (remimazolam+propofol or propofol) operation day - postoperative 1 day time from discontinuation of study drugs(remimazolam+propofol or propofol) to Bispectral index value \> 60