NCT07377695

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
57mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Feb 2026Dec 2030

First Submitted

Initial submission to the registry

January 22, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 4, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

January 22, 2026

Last Update Submit

April 22, 2026

Conditions

Moyamoya Disease

Outcome Measures

Primary Outcomes (1)

  • Total Consumption of Remimazolam

    The total cumulative dose of remimazolam ($mg$) administered from the initiation of anesthesia induction until the completion of the surgical procedure.

    From the start of anesthesia induction to the end of surgery (intraoperative period).

Study Arms (2)

TCI

EXPERIMENTAL

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

Other: Target-Controlled Infusion (TCI) of Remimazolam

Manual Infusion

ACTIVE COMPARATOR

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

Other: Manual Infusion of Remimazolam

Interventions

Target-Controlled Infusion (TCI) of RemimazolamOTHER

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.

TCI
Manual Infusion of RemimazolamOTHER

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.

Manual Infusion

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

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

RECRUITING

MeSH Terms

Conditions

Moyamoya Disease

Interventions

Transcobalaminsremimazolam

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Arterial DiseasesIntracranial Arterial DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsCarrier ProteinsGlobulins

Central Study Contacts

Chang-Hoon Koo

CONTACT

+82317877512vollock9@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 30, 2026

Study Start

February 4, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2030

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)