NCT07620782 Response Surface Modeling of Remimazolam and Sevoflurane
| NCT ID | NCT07620782 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pusan National University Yangsan Hospital |
| Condition | Laparoscopic Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-05-15 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-05-15 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This prospective randomized open-label study aims to investigate the pharmacodynamic interaction between remimazolam and sevoflurane during general anesthesia using response surface modeling. Although remimazolam has favorable hemodynamic stability compared with propofol, its hypnotic effect may be less predictable and poorly correlated with conventional sedation monitoring indices such as the bispectral index (BIS). In clinical practice, remimazolam and sevoflurane are often combined during induction and maintenance of anesthesia; however, the optimal interaction between these agents remains unclear. This study will evaluate whether the interaction between remimazolam and sevoflurane is synergistic, additive, or infra-additive using two representative response surface interaction models: the Minto model and the Greco model. BIS values and predicted effect-site concentrations will be analyzed using NONMEM software.
Eligibility Criteria
Inclusion Criteria: * Adults aged 20 to 80 years * Scheduled for elective surgery under general anesthesia at Pusan National University Yangsan Hospital * American Society of Anesthesiologists (ASA) physical status I or II * Able to provide written informed consent Exclusion Criteria: * Known allergy to remimazolam or sevoflurane * Renal, hepatic, neuromuscular, or neurological disease * Use of medications affecting the central nervous system * Chronic psychoactive drug use * Ischemic heart disease * Pregnant women
Contact & Investigator
Hee Young Kim, MD, PhD
PRINCIPAL INVESTIGATOR
Pusan National University Yangsan Hospital, Yangsan, South Korea
Frequently Asked Questions
Who can join the NCT07620782 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Laparoscopic Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07620782 currently recruiting?
Yes, NCT07620782 is actively recruiting participants. Contact the research team at anekhy@gmail.com for enrollment information.
Where is the NCT07620782 trial being conducted?
This trial is being conducted at Yangsan, South Korea.
Who is sponsoring the NCT07620782 clinical trial?
NCT07620782 is sponsored by Pusan National University Yangsan Hospital. The principal investigator is Hee Young Kim, MD, PhD at Pusan National University Yangsan Hospital, Yangsan, South Korea. The trial plans to enroll 80 participants.