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

Browse trials for

• Pneumoperitoneum 149

Keywords

• remimazolam
• propofol
• hemodynamics
• laparoscopic surgery
• general anesthesia
• Trendelenburg position
• pneumoperitoneum
• gynecologic surgery
• total intravenous anesthesia (TIVA)

Pneumoperitoneum

149 studies on the registry are indexed under Pneumoperitoneum; 29 are open to participants now.

This study's planned enrollment of 58 is below the median of 79 across 96 interventional studies indexed under Pneumoperitoneum.

Lead sponsor

Ilsan Cha hospital is the lead sponsor of 8 studies on the registry; 5 are open to participants now.

Study arms

• Experimental
  Group_R

  TIVA with remimazolam plus remifentanil

  Drug: Remimazolam

• Active comparator
  Group_P

  TIVA with propofol plus remifentanil

  Drug: Propofol

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.

  Also known as: Byfavo

• 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.

  Also known as: Fresofol MCT 2%

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).

Individual participant data

Plan to share: No — Individual participant data will not be shared. Summary results will be published in peer-reviewed journals and presented at scientific meetings.