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.
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 pressurewill 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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
58
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.
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.
CHA Ilsan Medical Center
Goyang-si, Gyeonggi-do, South Korea
CHA Ilsan Medical Center
Goyang-si, South Korea
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.
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).
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).
Joohyun Lee Assistant Professor, Dept. of Anesthesiology and Pain Medicine, MD
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