Comparison of Remimazolam and Propofol Combination vs. Propofol in Intraoperative Neurophysiologic Monitoring: A Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Remimazolam besylate + propofol MCT
- Conditions
- Neurologic Disorder
- Sponsor
- Chung-Ang University Gwangmyeong Hospital
- Enrollment
- 56
- Primary Endpoint
- Incidence of intraoperative hypotension
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Jiwon Han
Assistant professor
Chung-Ang University Gwangmyeong Hospital
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
- •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
- •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.
Arms & Interventions
Combination group
Combination regimen (remimazolam plus propofol)
Intervention: Remimazolam besylate + propofol MCT
Propofol group
Propofol monotherapy
Intervention: Propofol MCT
Outcomes
Primary Outcomes
Incidence of intraoperative hypotension
Time Frame: operation day - postoperative 1 day
mean arterial pressure \< 65mmHg
Secondary Outcomes
- scores of neurophysiologic monitoring quality(operation day - postoperative 1 day)
- Amount and number of inotropic agents(operation day - postoperative 1 day)
- Incidence of participants' intraoperative involuntary movement(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)
- Time-weighted average of intraoperative hypotension(operation day - postoperative 1 day)
- recovery time of study drugs (remimazolam+propofol or propofol)(operation day - postoperative 1 day)