Moyamoya Disease
Conditions
Brief 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.
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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Contacts
CONTACTChang-Hoon Koo
Outcome results
None listed