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NCT Number: NCT07377695

Remimazolam Consumption: TCI vs. Manual Infusion

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.

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Key information

Conditions

Moyamoya Disease Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebral Arterial Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Target-Controlled Infusion (TCI) of Remimazolam

Other

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.

Manual Infusion of Remimazolam

Other

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 outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chang-Hoon Koo

CONTACT

[email protected]

+82317877512

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Comparison of Remimazolam Consumption According to Administration Method in Patients Undergoing Cerebrovascular Bypass Surgery: A Prospective Randomized Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2030
First posted
Jan 30, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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