Remimazolam Consumption: TCI vs. Manual Infusion

Seoul National University Hospital58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Enrollment

Conditions

Moyamoya Disease

Interventions

Target-Controlled Infusion (TCI) of RemimazolamOTHER

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 RemimazolamOTHER

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

Total Consumption of Remimazolam

The total cumulative dose of remimazolam ($mg$) administered from the initiation of anesthesia induction until the completion of the surgical procedure.

Time frame: From the start of anesthesia induction to the end of surgery (intraoperative period).

Central Contacts

Chang-Hoon Koo

CONTACT

+82317877512 vollock9@gmail.com

Data from ClinicalTrials.gov

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