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

A Randomized, Parallel, Open-label With Blinded Assessment Study Comparing Hemodynamic Profiles Between Remimazolam- and Propofol-based Total Intravenous Anesthesia in Patients Undergoing Robot-assisted Gynecologic Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia, Intravenous; Gynecologic Surgery; Hemodynamic Stability
• Intervention / Treatment: Drug: Remimazolam; Drug: Propofol

Detailed 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 pressure will 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.

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joohyun Lee Assistant Professor, Dept. of Anesthesiology and Pain Medicine, MD; Phone Number: +82-31-782-8415; Email: hightothesky1004@gmail.com

Study Locations

• South Korea
  • Goyang-si, South Korea
    • Cha Ilsan Medical Center
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, South Korea, 10414
      • Cha Ilsan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group_R; TIVA with remimazolam plus remifentanil	Drug: 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.; Other Names: Byfavo
Active Comparator: Group_P; TIVA with propofol plus remifentanil	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.; Other Names: Fresofol MCT 2%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MAP (Time-Weighted Average)	Continuous invasive arterial pressure is recorded throughout anesthesia. For each participant, TWA-MAP is computed as the integral of MAP over elapsed time divided by total observation time (trapezoidal rule). Data are aggregated at ~1-min resolution when possible. Implausible artifacts (e.g., MAP <30 or >180 mmHg) are excluded. The primary comparison is the between-group difference in TWA-MAP (remimazolam vs propofol) for validating hypothesis (remimazolam-based TIVA maintains ≥20% higher intraoperative MAP than propofol-based TIVA). Primary analysis will use ANCOVA adjusting for baseline MAP and prespecified covariates, with a one-sided significance level of 0.05.	from induction start (first anesthetic administration) to operating room exit (transfer from OR), approximately up to 5 hours per participant.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve (AUC) for Hypertensive Burden	Continuous invasive arterial pressure is recorded throughout anesthesia. For each participant, the AUC above the hypertensive threshold (SBP ≥140 mmHg or MAP ≥100 mmHg) is calculated as mmHg·minutes using the trapezoidal rule. This measure represents the cumulative burden of intraoperative hypertension. Group comparisons will assess whether remimazolam-based TIVA differs from propofol-based TIVA in hypertensive burden.	from anesthesia induction to operating room exit, assessed continuously during surgery (approximately 2 to 5 hours per participant).
Area Under the Curve (AUC) for Hypotensive Burden	Continuous invasive arterial pressure is recorded throughout anesthesia. For each participant, the AUC below the hypotensive threshold (SBP <90 mmHg or MAP <65 mmHg) is calculated as mmHg·minutes using the trapezoidal rule. This measure represents the cumulative burden of intraoperative hypotension. Group comparisons will assess whether remimazolam-based TIVA differs from propofol-based TIVA in hypotensive burden.	from anesthesia induction to operating room exit, assessed continuously during surgery (approximately 2 to 5 hours per participant).

Collaborators and Investigators

• Sponsor: Ilsan Cha hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 2, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: September 25, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: general anesthesia; gynecologic surgery; hemodynamics; laparoscopic surgery; propofol; pneumoperitoneum; Trendelenburg position; remimazolam; total intravenous anesthesia (TIVA)
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Propofol; remimazolam
• Other Study ID Numbers: ICHA 2025-07-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. Summary results will be published in peer-reviewed journals and presented at scientific meetings.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No