NCT07789275|Not Yet RecruitingPhase 4
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Sponsor study identifier
interventional
224
1 country
1
Study Start
August 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 21, 2026
Actual (reported)August 27, 2026
Actual (reported)July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Time-weighted average of mean arterial pressure below 65 mmHg during liver parenchymal transection
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.
From the start to the completion of liver parenchymal transection under low central venous pressure management, intraoperative
Cumulative norepinephrine-equivalent dose during liver parenchymal transection
From the start to the completion of liver parenchymal transection under low central venous pressure management, intraoperative
Participants will receive a common intravenous induction regimen of etomidate 0.2 mg/kg, sufentanil 0.3 micrograms/kg, and cisatracurium 0.2 mg/kg. After tracheal intubation, remimazolam will be infused at 1.0 to 2.0 mg/kg/hour for maintenance of total intravenous anesthesia. The infusion will be titrated to a bispectral index of 40 to 60, clinical signs, and surgical stimulation and will be stopped when emergence is planned. Standardized low central venous pressure and hypotension-management protocols will be applied.
Participants will receive a common intravenous induction regimen of etomidate 0.2 mg/kg, sufentanil 0.3 micrograms/kg, and cisatracurium 0.2 mg/kg. After tracheal intubation, propofol will be infused at 4.0 to 10.0 mg/kg/hour for maintenance of total intravenous anesthesia. The infusion will be titrated to a bispectral index of 40 to 60, clinical signs, and surgical stimulation and will be stopped when emergence is planned. Standardized low central venous pressure and hypotension-management protocols will be applied.
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.
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.
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
First Submitted
August 21, 2026
First Posted
August 27, 2026
Study Start
August 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Number of participants receiving any vasopressor during liver parenchymal transection
From the start to the completion of liver parenchymal transection under low central venous pressure management, intraoperative
Time-weighted average of mean arterial pressure below 65 mmHg during maintenance anesthesia
From the start to the final discontinuation of the allocated maintenance anesthetic, intraoperative
Estimated intraoperative blood loss
From surgical incision to completion of surgery, intraoperative
Number of participants receiving intraoperative red blood cell transfusion
During surgery, intraoperative
Number of participants with acute kidney injury within 7 postoperative days
From the end of surgery through postoperative Day 7
Number of participants with grade B or C post-hepatectomy liver failure
From postoperative day 5 through hospital discharge, assessed up to postoperative day 30
Number of participants with severe hypotension during maintenance anesthesia
From the start to the final discontinuation of the allocated maintenance anesthetic, intraoperative
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July 2027
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 27, 2026
Record last verified: 2026-08
Individual participant data will not be shared with researchers outside the study team because the current ethics approval and informed consent form do not authorize external sharing of participant-level data. De-identified aggregate results will be reported in scientific publications and the trial registry, as applicable.
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Source: ClinicalTrials.gov.
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