Hemodynamic Effects of Remimazolam vs Propofol During Robot-assisted Gynecologic Surgery

NCT ID: NCT07251101

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-02

Study Completion Date

2027-09-30

Brief Summary

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This single-center study at CHA Ilsan Medical Center compares intraoperative hemodynamics between remimazolam- and propofol-based total intravenous anesthesia (TIVA) in patients undergoing robot-assisted gynecologic surgery requiring pneumoperitoneum and steep Trendelenburg positioning.

Detailed Description

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This study aims to compare intraoperative hemodynamic characteristics between remimazolam- and propofol-based total intravenous anesthesia (TIVA) in patients undergoing robot-assisted gynecologic surgery. Continuous invasive blood pressurewill be analyzed to evaluate time-weighted average (TWA) and area-under-the-curve (AUC) differences between groups. The study is designed as a randomized, parallel, open-label with blinded assessment trial.

Conditions

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Anesthesia, Intravenous Hemodynamic Stability Gynecologic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group_R

TIVA with remimazolam plus remifentanil

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

Induction with remimazolam 6 mg·kg-¹·h-¹ with remifentanil Ce 4 ng·mL-¹ (Minto model); maintenance remimazolam 1-2 mg·kg-¹·h-¹, titrated (±0.2) to maintain PSI 25-50 and hemodynamic targets. Standard care otherwise per protocol.

Group_P

TIVA with propofol plus remifentanil

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Induction with propofol Ce 4 ng·mL-¹ with remifentanil Ce 4 ng·mL-¹; maintenance propofol Ce 2.5-3.5 ng·mL-¹, titrated (±0.2) to maintain PSI 25-50 and hemodynamic targets. Standard care otherwise per protocol.

Interventions

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Remimazolam

Induction with remimazolam 6 mg·kg-¹·h-¹ with remifentanil Ce 4 ng·mL-¹ (Minto model); maintenance remimazolam 1-2 mg·kg-¹·h-¹, titrated (±0.2) to maintain PSI 25-50 and hemodynamic targets. Standard care otherwise per protocol.

Intervention Type DRUG

Propofol

Induction with propofol Ce 4 ng·mL-¹ with remifentanil Ce 4 ng·mL-¹; maintenance propofol Ce 2.5-3.5 ng·mL-¹, titrated (±0.2) to maintain PSI 25-50 and hemodynamic targets. Standard care otherwise per protocol.

Intervention Type DRUG

Other Intervention Names

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Byfavo Fresofol MCT 2%

Eligibility Criteria

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Inclusion Criteria

* Female patients \<65 years of age
* American Society of Anesthesiologists (ASA) physical status I-II
* Scheduled to undergo robotic hysterectomy under general anesthesia

Exclusion Criteria

* Body mass index (BMI) \> 35 kg/m²
* Baseline hypotension (systolic blood pressure \<100 mmHg) or bradycardia (heart rate \<60 bpm)
* History of ischemic heart disease or cardiac conduction block
* Significant cardiopulmonary disease, including hypoxemia (SpO₂ \<90%), uncontrolled asthma, or chronic obstructive pulmonary disease (COPD)
* Use of inhalational anesthetics during anesthesia
* Conversion from robotic/laparoscopic surgery to open laparotomy
Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ilsan Cha hospital

OTHER

Sponsor Role lead

Responsible Party

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Joohyun Lee

Assistant Professor, Department of Anesthesiology and Pain Medicine, CHA University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHA Ilsan Medical Center

Goyang-si, Gyeonggi-do, South Korea

Site Status

CHA Ilsan Medical Center

Goyang-si, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Joohyun Lee Assistant Professor, Dept. of Anesthesiology and Pain Medicine, MD

Role: CONTACT

+82-31-782-8415

Other Identifiers

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ICHA 2025-07-005

Identifier Type: -

Identifier Source: org_study_id

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