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

ConditionsAnesthesia, IntravenousHemodynamic StabilityGynecologic Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeUp to 65
SponsorIlsan Cha hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients <65 years of age

American Society of Anesthesiologists (ASA) physical status I-II

Scheduled to undergo robotic hysterectomy under general anesthesia

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: Group_RExperimental treatment 1 intervention
Group B: Group_PActive comparator 1 intervention

Trial outcomes

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.

Time frame
from induction start (first anesthetic administration) to operating room exit (transfer from OR), approximately up to 5 hours per participant.

Secondary outcomes

1

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.

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

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ilsan Cha hospital

Lead sponsor

Source ClinicalTrials.gov

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