REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age45+
SponsorNanfang Hospital, Southern Medical University
About this trial
The goal of this randomized controlled trial is to compare total intravenous anesthesia with remimazolam vs total intravenous anesthesia with propofol in moderate-to-high risk patients undergoing major elective noncardiac surgery under general anesthesia. The primary hypothesis is that total intravenous anesthesia with remimazolam can increase days alive and out of hospital at postoperative day 30 compared with total intravenous anesthesia with propofol.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥45 years;
Undergoing elective major surgery under general anesthesia (expected surgery time >2 h, expected length of postoperative stay >2 d);
history of coronary artery disease;
history of stroke;
Disqualifiers
Undergoing organ transplantation, cardiac, craniocerebral, burn or interventional operations;
Low risk or minor surgery
End-stage renal disease requiring renal-replacement therapy;
Hepatic dysfunction (Child B or C);
Trial design
Design model
Parallel
Treatments tested in this trial
Remimazolam
DrugRemimazolam is administered intravenously for induction and maintenance of general anesthesia.
Propofol
DrugPropofol is administered intravenously for induction and maintenance of general anesthesia.
Treatment groups
7,188 Participants
are divided into 2 treatment groupsGroup A: Remimazolam TIVAExperimental treatment 1 intervention
Group B: Propofol TIVAActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Days alive and out of hospital at day 30
Number of days alive and out of hospital
Time frame
30 days after randomizationSecondary outcomes
1
All-cause 30-day mortality
Number of patients who die of any cause
Time frame
30 days after randomization2
Length of hospital stay
Number of days in hospital
Time frame
30 days after randomization3
Unplanned re-hospitalization
Number of patients who experience unplanned hospital re-admissions
Time frame
30 days after randomization4
Postoperative complications
Number of patients who experience postoperative complications
Time frame
30 days after randomizationOther outcomes
1
Cancer recurrence
Number of patients who experience cancer recurrence after radical resection of cancer
Time frame
3 years after randomization2
All-cause 3-year mortality
Number of patients who die of any cause
Time frame
3 years after randomizationSponsors and contacts
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Source ClinicalTrials.gov