REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry (REPOSE-2)

Nanfang Hospital, Southern Medical University

Status and phase: Enrolling; Phase 4

Conditions: Surgery-Complications; Anesthesia

Treatments: Drug: Propofol; Drug: Remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT05728775

NFEC-2022-286

Details and patient eligibility

About

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.

Enrollment: 7,188 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥45 years;

• Undergoing elective major surgery under general anesthesia (expected surgery time >2 h, expected length of postoperative stay >2 d);

• Fulfilling ≥1 of the following criteria:

  1. history of coronary artery disease;
  2. history of stroke;
  3. history of congestive heart failure;
  4. preoperative NT-proBNP >200 pg/mL or BNP>92 pg/mL;
  5. age ≥70 years;
  6. diabetes requiring medical treatment;
  7. ASA status 3 or 4;
  8. history of chronic kidney disease (preoperative sCr >133 μmol/L or 1.5 mg/dL);
  9. history of peripheral arterial disease;
  10. preoperative serum albumin <30 g/L;
  11. preoperative hemoglobin <100 g/L.

Exclusion criteria

• 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);
• Previous liver or kidney transplantation;
• Previous allergy to general anesthetics;
• Unable to receive bispectral index monitoring;
• ASA score ≥5;
• Exposure to general anesthesia in prior 30 days or anticipated re-exposure to general anesthesia within 30 days after surgery;
• Need for prolonged airway protection or mechanical ventilatory support after surgery;
• Current participation in another interventional study;
• Previous participation in this study;
• Pregnant or breastfeeding women.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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7,188 participants in 2 patient groups

Remimazolam TIVA

Experimental group

Description:

Remimazolam is administered at 6-12 mg/kg/h intravenously for anesthesia induction and at 1.0-2.0 mg/kg/h for maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60.

Treatment:

Drug: Remimazolam

Propofol TIVA

Active Comparator group

Description:

Propofol 1.5-2.5mg/kg is administered intravenously for anesthesia induction and propofol at 4-12mg/kg/h is used for maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60.

Treatment:

Drug: Propofol