Moyamoya DiseaseNCT07377695
Remimazolam Consumption: TCI vs. Manual Infusion
A study testing Manual Infusion of Remimazolam in people with Moyamoya Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Moyamoya Disease
- What is being tested?
- Manual Infusion of Remimazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Feb 2026to 31 Dec 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: Comparison of Remimazolam Consumption According to Administration Method in Patients Undergoing Cerebrovascular Bypass Surgery: A Prospective Randomized Trial
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.
- Conditions
- Moyamoya Disease
- Being tested
- Target-Controlled Infusion (TCI) of Remimazolam, Manual Infusion of Remimazolam
- Medical subject headings
- Moyamoya Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| TCI | Experimental | Remimazolam administered via TCI (target Ce 0.7 μg/mL) Receives: 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) Receives: Other: Manual Infusion of Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the start of anesthesia induction to the end of surgery (intraoperative period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start4 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moyamoya DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Hoon Koo, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377695
- Sponsor's protocol ID
- Bypass-TCI
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No