Remimazolam Consumption: TCI vs. Manual Infusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Target-Controlled Infusion (TCI) of Remimazolam, Manual Infusion of Remimazolam.
- Who it may be relevant to
- Registry conditions: Moyamoya Disease. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Remimazolam Consumption According to Administration Method in Patients Undergoing Cerebrovascular Bypass Surgery: A Prospective Randomized Trial
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.
Interventions
- Other 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. - Other 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.
Primary outcome measures
- Total Consumption of Remimazolam [Time frame: From the start of anesthesia induction to the end of surgery (intraoperative period).]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Health services research
Study locations
South Korea · 1 center
- Seoul National University Bundang Hospital — Seongnam-si
Identifiers
NCT: NCT07377695 · Bypass-TCI