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

Ilsan Cha hospital

Status: Not yet enrolling

Conditions: Gynecologic Surgery; Hemodynamic Stability; Anesthesia, Intravenous

Treatments: Drug: Remimazolam; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT07251101

ICHA 2025-07-005

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 58 estimated patients

Sex: Female

Ages: Under 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 2 patient groups

Group_R

Experimental group

Description:

TIVA with remimazolam plus remifentanil

Treatment:

Drug: Remimazolam

Group_P

Active Comparator group

Description:

TIVA with propofol plus remifentanil

Treatment:

Drug: Propofol