Remimazolam: target-controlled infusion versus manual infusion during cerebrovascular bypass
Comparison of Remimazolam Consumption According to Administration Method in Patients Undergoing Cerebrovascular Bypass Surgery: A Prospective Randomized Trial
This trial will test whether target-controlled infusion uses less remimazolam than manual infusion in adults undergoing cerebrovascular bypass surgery for moyamoya disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Trial ID | NCT07377695 on ClinicalTrials.gov |
What this trial studies
This prospective randomized controlled trial compares total remimazolam consumption between target-controlled infusion (TCI) and manual infusion in patients undergoing cerebrovascular bypass surgery. Adult patients (aged ≥19) with ASA physical status 1–3 who provide informed consent will be randomized to receive remimazolam by TCI or by manual infusion during general anesthesia. The primary outcome is total remimazolam use during the procedure, with intraoperative hemodynamic and safety data collected as secondary measures. The study is conducted at Seoul National University Bundang Hospital.
Who should consider this trial
Good fit: Adults aged 19 or older with moyamoya disease scheduled for cerebrovascular bypass under general anesthesia, ASA 1–3, who can provide informed consent and meet safety criteria.
Not a fit: Patients who are ASA 4, have extreme BMI (<18.5 or ≥35 kg/m2), benzodiazepine allergy, acute narrow-angle glaucoma, severe respiratory disorders (including untreated sleep apnea), alcohol or drug dependency, or lactose/dextran hypersensitivity are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, the trial could identify a dosing method that reduces remimazolam use and improves dosing precision and perioperative stability.
How similar studies have performed: While TCI has improved dosing precision for other intravenous anesthetics, applying TCI specifically to remimazolam in cerebrovascular bypass is relatively novel with limited published evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seongnam-si, Gyeonggi-do
- Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Study coordinator: Chang-Hoon Koo
- Email: vollock9@gmail.com
- Phone: +82317877512
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.