REmimazolam vs PrOpofol on Intraoperative hypotenSion in Major Noncardiac surgEry

NCT ID: NCT05436522

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-22
• Study Completion Date: 2024-06-21

Brief Summary

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.

Conditions

Intraoperative Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Remimazolam TIVA

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

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

Remimazolam is administered intravenously for induction and maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60.

Propofol TIVA

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

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Propofol is administered intravenously for induction and maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60.

Interventions

Remimazolam

Remimazolam is administered intravenously for induction and maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60.

Intervention Type: DRUG

Propofol

Propofol is administered intravenously for induction and maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanfang Hospital, Southern Medical University

Guangzhou, , China

Countries

China

Other Identifiers

NFEC-2021-260

Identifier Type: -

Identifier Source: org_study_id