Remimazolam Consumption: TCI vs. Manual Infusion

Seoul National University

Status: Not yet enrolling

Conditions: Moyamoya Disease

Treatments: Other: Manual Infusion of Remimazolam; Other: Target-Controlled Infusion (TCI) of Remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT07377695

Bypass-TCI

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 2 patient groups

TCI

Experimental group

Description:

Remimazolam administered via TCI (target Ce 0.7 μg/mL)

Treatment:

Other: Target-Controlled Infusion (TCI) of Remimazolam

Manual Infusion

Active Comparator group

Description:

Remimazolam administered via manual infusion (6 mg/kg/hr for induction, 1-2 mg/kg/hr for maintenance)

Treatment:

Other: Manual Infusion of Remimazolam