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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group_R | Experimental | TIVA with remimazolam plus remifentanil |
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| Group_P | Active Comparator | TIVA with propofol plus remifentanil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joohyun Lee Assistant Professor, Dept. of Anesthesiology and Pain Medicine, MD | Contact | +82-31-782-8415 | hightothesky1004@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Ilsan Medical Center | Goyang-si | Gyeonggi-do | 10414 | South Korea | ||
| CHA Ilsan Medical Center |
Individual participant data will not be shared. Summary results will be published in peer-reviewed journals and presented at scientific meetings.
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| ID | Term |
|---|---|
| D011027 | Pneumoperitoneum |
| ID | Term |
|---|---|
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| 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. |
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| 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. | from anesthesia induction to operating room exit, assessed continuously during surgery (approximately 2 to 5 hours per participant). |
| Goyang-si |
| South Korea |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |