Remimazolam Consumption: TCI vs. Manual Infusion

NCT07377695 · tracked via the Priya Life Science South Korea tracker

Sponsor

Seoul National University Hospital

Phase

Not applicable

Started

2026-02-04

Last updated

2026-04-23

Condition(s) studied

Moyamoya Disease

Investigational drug(s) / intervention(s)

Target-Controlled Infusion (TCI) of RemimazolamManual Infusion of Remimazolam

Target-Controlled Infusion (TCI) of Remimazolam: Remimazolam is administered using a target-controlled infusion (TCI) pump based on the Schuttler pharmacokinetic model. The initial target effect-site concentration (Ce) is set at 0.7 μg/mL and adjusted in 0.1 μg/mL increments to maintain a depth of anesthesia between Patient State Index (PSi) 25 and 50.

Manual Infusion of Remimazolam: Remimazolam is administered via traditional manual weight-based infusion. For anesthesia induction, a rate of 6 mg/kg/hr is used. For maintenance, the infusion rate starts at 1 mg/kg/hr and is adjusted in 0.2 mg/kg/hr increments to maintain a PSi between 25 and 50.

Study summary

The purpose of this prospective randomized controlled trial is to compare the total consumption of remimazolam between two different administration methods-Target-Controlled Infusion (TCI) and manual infusion-in patients undergoing cerebrovascular bypass surgery.

Eligibility

Sex

ALL

Min age

19 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients scheduled to undergo cerebrovascular bypass surgery under general anesthesia. * American Society of Anesthesiologists (ASA) Physical Status 1, 2, or 3 * Adults aged 19 years or older * Patients who have provided prior written informed consent to participate in the study Exclusion Criteria: * Patients who do not consent to participate in the research * Patients classified as ASA Physical Status 4 * Patients with a BMI ≤18.5 kg/m2 or 35.0 ≥ kg/m2 * History of allergy to benzodiazepine-class medications * Patients with acute narrow-angle glaucoma * Patients in a state of shock or coma * Acute alcohol intoxication with suppressed vital signs , or patients with alcohol or drug dependency * Presence of Sleep Apnea Syndrome or severe/acute respiratory failure * Patients with lactose intolerance or hypersensitivity to Dextran 40

Primary outcome measure(s)

Total Consumption of Remimazolam — From the start of anesthesia induction to the end of surgery (intraoperative period).
The total cumulative dose of remimazolam ($mg$) administered from the initiation of anesthesia induction until the completion of the surgical procedure.

Trial sites (1)

Facility	City	Region	Status
Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07377695 on ClinicalTrials.gov ↗ ← All trials in South Korea