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Remimazolam Consumption: TCI vs. Manual Infusion

NCT07377695 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

  • Moyamoya Disease

Interventions

OTHER

Target-Controlled Infusion (TCI) of Remimazolam

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.

OTHER

Manual Infusion of Remimazolam

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.

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-04
Primary Completion
2026-12-31
Completion
2030-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07377695 on ClinicalTrials.gov