REmimazolam vs PrOpofol on Intraoperative hypotenSion in Major Noncardiac surgEry (REPOSE-1)

Nanfang Hospital, Southern Medical University

Status and phase: Completed; Phase 4

Conditions: Intraoperative Hypotension

Treatments: Drug: Remimazolam; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT05436522

NFEC-2021-260

Details and patient eligibility

About

Intraoperative hypotension is common during major noncardiac surgery and is associated with adverse postoperative outcomes. Propofol, the most commonly used intravenous anesthetic agent worldwide, is associated with hypotension on induction and maintenance of general anesthesia. Remimazolam is a newly developed short-acting benzodiazepine drug and has been approved for use in procedural sedation and general anesthesia. It was associated with a lower incidence of hypotension during procedural sedation in previous studies. The aim of this study is to tested the primary hypothesis that total intravenous anesthesia with remimazolam reduces the duration and severity of hypotension during major noncardiac surgery compared with total intravenous anesthesia with propofol.

Enrollment: 340 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);

• Need for intraoperative invasive blood pressure monitoring via arterial line;

• Fulfilling ≥1 of the following criteria (a-k):

  1. history of coronary artery disease;
  2. history of stroke;
  3. history of congestive heart failure;
  4. preoperative NT-proBNP >200 pg/mL;
  5. preoperative high sensitivity troponin T > 14 ng/L;
  6. age ≥70 years;
  7. diabetes requiring medical treatment;
  8. ASA status 3 or 4;
  9. history of chronic kidney disease (preoperative sCr >133μmol/L or 1.5 mg/dL);
  10. preoperative serum albumin <30 g/L;
  11. preoperative hemoglobin <100 g/L.

Exclusion criteria

• Undergoing organ transplantation, cardiac, neurological, or adrenal gland surgery;
• Planned intraoperative MAP higher or lower than 65 mmHg;
• Severe untreated or uncontrolled hypertension (preoperative SBP >180 mmHg and/or DBP >110 mmHg);
• End-stage renal disease requiring renal-replacement therapy;
• ASA score ≥5;
• Preoperative requirement of vasopressor infusion;
• Unable to receive bispectral index monitoring;
• Known allergy to benzodiazepines, propofol, opioids or cisatracurium;
• Current participation in another interventional study;
• Previous participation in this study;
• Pregnant or breastfeeding women.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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340 participants in 2 patient groups

Remimazolam TIVA

Experimental group

Description:

Induction: Remimazolam, sufentanil, cisatracurium. Maintenance: Remimazolam, remifentanil, cisatracurium.

Treatment:

Drug: Remimazolam

Propofol TIVA

Active Comparator group

Description:

Induction: Propofol, sufentanil, cisatracurium. Maintenance: Propofol, remifentanil, cisatracurium.

Treatment:

Drug: Propofol