Comparison of Remimazolam Consumption According to Administration Method in Patients Undergoing Cerebrovascular Bypass Surgery: A Prospective Randomized Trial
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 58
- Locations
- 2
- Primary Endpoint
- Total Consumption of Remimazolam
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
TCI
Remimazolam administered via TCI (target Ce 0.7 μg/mL)
Intervention: Target-Controlled Infusion (TCI) of Remimazolam (Other)
Manual Infusion
Remimazolam administered via manual infusion (6 mg/kg/hr for induction, 1-2 mg/kg/hr for maintenance)
Intervention: Manual Infusion of Remimazolam (Other)
Outcomes
Primary Outcomes
Total Consumption of Remimazolam
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Chang-Hoon Koo
Associate professor
Seoul National University Hospital