Comparison of Remimazolam and Propofol Combination vs. Propofol in IOM

Neurologic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06382467
• Other study ID #: 2401-136-016
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 2024
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Chung-Ang University Gwangmyeong Hospital
• Contact: Jiwon Han, Pf.
• Phone: 821034471988
• Email: yesuroon[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurologic Disorder

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chung-Ang University Gwangmyeong Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of intraoperative hypotension	mean arterial pressure < 65mmHg	operation day - postoperative 1 day
Secondary	Amount and number of inotropic agents	intraoperative inotropics amount (phenylephrine(mcg), ephedrine(mg), norepinephrine(mcg), dopamine(mg))	operation day - postoperative 1 day
Secondary	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
Secondary	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
Secondary	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
Secondary	The administration number of rescue anti-emetic agents	postoperative rescue anti-emetic agents (ramosetron, palonosetron, metoclopramide) requirements	operation day - postoperative 3 day
Secondary	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
Secondary	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