Anesthesia, Intravenous, Gynecologic Surgery, Hemodynamic Stability
Conditions
Keywords
remimazolam, propofol, hemodynamics, laparoscopic surgery, general anesthesia, Trendelenburg position, pneumoperitoneum, gynecologic surgery, total intravenous anesthesia (TIVA)
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.
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
DRUGRemimazolam
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.
DRUGPropofol
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.
Sponsors
Ilsan Cha hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MAP (Time-Weighted Average) | from induction start (first anesthetic administration) to operating room exit (transfer from OR), approximately up to 5 hours per participant. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
| 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). | 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. |
Countries
South Korea
Contacts
CONTACTJoohyun Lee Assistant Professor, Dept. of Anesthesiology and Pain Medicine, MD
Outcome results
None listed