Comparison of Remimazolam and Propofol Combination vs. Propofol in IOM

Comparison of Remimazolam and Propofol Combination vs. Propofol in Intraoperative Neurophysiologic Monitoring: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neurologic Disorder
• Intervention / Treatment: Drug: Remimazolam besylate + propofol MCT; Drug: Propofol MCT

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.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jiwon Han, Pf.; Phone Number: 821034471988; Email: yesuroon@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination group; Combination regimen (remimazolam plus propofol)	Drug: 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
Active Comparator: Propofol group; Propofol monotherapy	Drug: Propofol MCT; Propofol MCT 2-8 mcg/ml using target-controlled infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative hypotension	mean arterial pressure < 65mmHg	operation day - postoperative 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount and number of inotropic agents	intraoperative inotropics amount (phenylephrine(mcg), ephedrine(mg), norepinephrine(mcg), dopamine(mg))	operation day - postoperative 1 day
Incidence of participants' intraoperative involuntary movement	number of patients involuntary movement during operation (ex. no movement:0 , 3 times of movement: 3)	operation day - postoperative 1 day
scores of neurophysiologic monitoring quality	0-5 scale of neurophysiologic monitoring quality, scored by neurophysiologic monitoring technologist (poor: 0, good: 5)	operation day - postoperative 1 day
onset time of study drugs	time from administration of study drugs(remimazolam+propofol or propofol) to Bispectral index value < 60	operation day - postoperative 1 day
The administration number of rescue anti-emetic agents	postoperative rescue anti-emetic agents (ramosetron, palonosetron, metoclopramide) requirements	operation day - postoperative 3 day
Time-weighted average of intraoperative hypotension	(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	operation day - postoperative 1 day
recovery time of study drugs (remimazolam+propofol or propofol)	time from discontinuation of study drugs(remimazolam+propofol or propofol) to Bispectral index value > 60	operation day - postoperative 1 day

Collaborators and Investigators

• Sponsor: Chung-Ang University Gwangmyeong Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 21, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 21, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: 2401-136-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No