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

Qualifiers

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

Treatments tested in this trial

  • Remimazolam
  • Propofol

Treatment groups

7,188 Participants
are divided into 2 treatment groups