Remimazolam Consumption: TCI vs. Manual Infusion
ConditionMoyamoya Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Target-Controlled Infusion (TCI) of Remimazolam
Other interventionRemimazolam 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
Other interventionRemimazolam 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.
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: TCIExperimental treatment 1 intervention
Group B: Manual InfusionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).Sponsors and contacts
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Source ClinicalTrials.gov