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

NCT07251101 | Not Yet Recruiting

• 1 other identifier: ICHA 2025-07-005
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Anesthesia, Intravenous; Hemodynamic Stability; Gynecologic Surgery

Keywords

remimazolam; propofol; hemodynamics; laparoscopic surgery; general anesthesia; Trendelenburg position; pneumoperitoneum; gynecologic surgery; total intravenous anesthesia (TIVA)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Area Under the Curve (AUC) for 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

  from anesthesia induction to operating room exit, assessed continuously during surgery (approximately 2 to 5 hours per participant).

Study Arms (2)

Group_R

EXPERIMENTAL

TIVA with remimazolam plus remifentanil

Drug: Remimazolam

Group_P

ACTIVE COMPARATOR

TIVA with propofol plus remifentanil

Drug: Propofol

Interventions

Remimazolam 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.

Also known as: Byfavo

Group_R

Propofol 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.

Also known as: Fresofol MCT 2%

Group_P

Eligibility Criteria

• Age: Up to 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ilsan Cha hospital: lead

Study Sites (2)

CHA Ilsan Medical Center

Goyang-si, Gyeonggi-do, 10414, South Korea

Location

CHA Ilsan Medical Center

Goyang-si, South Korea

Location

MeSH Terms

Conditions

Pneumoperitoneum

Interventions

remimazolam; Propofol

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

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

CONTACT

+82-31-782-8415; hightothesky1004@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anesthesiology and Pain Medicine, CHA University

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: November 26, 2025
• Study Start: May 2, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)