Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure

Condition(s) studied

Investigational drug(s) / intervention(s)

Remimazolam: After a common etomidate-based induction regimen and tracheal intubation, intravenous remimazolam will be infused at 1.0 to 2.0 mg/kg/hour for maintenance of general anesthesia. The dose will be titrated to a bispectral index of 40 to 60, clinical signs, and surgical stimulation. The infusion will be stopped when emergence is planned. Flumazenil will not be administered routinely.

Propofol: After a common etomidate-based induction regimen and tracheal intubation, intravenous propofol will be infused at 4.0 to 10.0 mg/kg/hour for maintenance of general anesthesia. The dose will be titrated to a bispectral index of 40 to 60, clinical signs, and surgical stimulation. The infusion will be stopped when emergence is planned.

Study summary

The goal of this clinical trial is to learn whether remimazolam helps prevent low blood pressure better than propofol during major liver surgery in adults. All participants will have planned surgery to remove at least three liver segments.

The main question is whether participants who receive remimazolam have less low blood pressure while the surgeon removes liver tissue. Researchers will measure both how low the blood pressure falls and how long it stays low.

Researchers will randomly assign 224 participants to receive remimazolam or propofol to maintain general anesthesia. Participants will not know which drug they receive until their postoperative assessments are complete. The anesthesiologist giving the drug will know the assignment for safety reasons.

Participants will:

* Receive one of the two study drugs during surgery
* Have their blood pressure monitored continuously
* Receive standard treatment if their blood pressure becomes low
* Complete follow-up through 30 days after surgery

Researchers will also compare the use of medicines to support blood pressure, bleeding, blood transfusion, recovery after anesthesia, organ complications, heart injury, and adverse events.

Eligibility

Primary outcome measure(s)

• Time-weighted average of mean arterial pressure below 65 mmHg during liver parenchymal transection — From the start to the completion of liver parenchymal transection under low central venous pressure management, intraoperative
  The time-weighted average will quantify the depth and duration of hypotension during the complete period of liver parenchymal transection under low central venous pressure management. It will be calculated from quality-assessed invasive arterial pressure measurements. For periods when mean arterial pressure is below 65 mmHg, the difference between 65 mmHg and the observed pressure will be integrated over time. The resulting area will be divided by the duration of valid arterial pressure monitoring. The unit is mmHg. A value of 0 indicates that no valid mean arterial pressure measurement was below 65 mmHg. Higher values indicate a greater hypotension burden.

Trial sites (1)

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