RecruitingNot ApplicableNCT07377695

Remimazolam Consumption: TCI vs. Manual Infusion

Comparison of Remimazolam Consumption According to Administration Method in Patients Undergoing Cerebrovascular Bypass Surgery: A Prospective Randomized Trial

Sponsor

Seoul National University Hospital

Enrollment

58 participants

Start Date

Feb 4, 2026

Study Type

INTERVENTIONAL

Conditions

Moyamoya Disease

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

Min Age: 19 Years

Inclusion Criteria4

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 Criteria9

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

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Interventions

OTHERTarget-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.

OTHERManual 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.