Hemodynamic Effects of Remimazolam vs Propofol During Robot-assisted Gynecologic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remimazolam, Propofol.
- Who it may be relevant to
- Registry conditions: Anesthesia, Intravenous, Hemodynamic Stability, Gynecologic Surgery. Basic parameters: up to 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
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.
Interventions
- 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. - 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.
Primary outcome measures
- MAP (Time-Weighted Average) [Time frame: from induction start (first anesthetic administration) to operating room exit (transfer from OR), approximately up to 5 hours per participant.]
Secondary outcome measures (2)
- Area Under the Curve (AUC) for Hypertensive Burden [Time frame: 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 [Time frame: from anesthesia induction to operating room exit, assessed continuously during surgery (approximately 2 to 5 hours per participant).]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
South Korea · 2 centers
- CHA Ilsan Medical Center — Goyang-si
- CHA Ilsan Medical Center — Goyang-si
Publications
- Lee JM, Lee J, Kang SH, Jung K, Yeo H, Lee JY, Joo Y. Comparison of intraoperative hemodynamic parameters between propofol- and remimazolam-based total intravenous anesthesia in patients undergoing robotic gynecologic surgery: a randomized controlled trial protocol. Front Pharmacol. 2026 Jul 20;17:1775804. doi: 10.3389/fphar.2026.1775804. eCollection 2026. PMID 42544348
Identifiers
NCT: NCT07251101 · ICHA 2025-07-005