REmimazolam vs PrOpofol on Intraoperative hypotenSion in Major Noncardiac surgEry

Phase 4

Completed

• Conditions: Intraoperative Hypotension
• Interventions: Drug: Propofol; Drug: Remimazolam

• Registration Number: NCT05436522
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-29
• Study Start: 2022-08-22
• Primary Completion: 2024-05-21
• Study Completion: 2024-06-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol TIVA	Propofol	Induction: Propofol, sufentanil, cisatracurium. Maintenance: Propofol, remifentanil, cisatracurium.
Remimazolam TIVA	Remimazolam	Induction: Remimazolam, sufentanil, cisatracurium. Maintenance: Remimazolam, remifentanil, cisatracurium.

Primary Outcome Measures

Name	Time	Method
Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 65 mmHg.	MAP measurements are recorded every minute from of anesthesia induction to end of wound closure.	TWA-MAP under 65 mmHg for each patient is derived by dividing area under the curve (AUC)-MAP under 65 mmHg by the time interval between the first and the last MAP measurements.

Secondary Outcome Measures

Name	Time	Method
AUC-MAP under 65 mmHg.	From of anesthesia induction to end of wound closure.	AUC-MAP under 65 mmHg for each patient is derived by depth of hypotension in millimeters of mercury below a MAP of 65 mmHg × time in minutes spent below a MAP of 65 mmHg.
Duration of MAP under 65 mmHg.	From of anesthesia induction to end of wound closure.	Duration of MAP under 65 mmHg is the total amount of time in minutes that the MAP is under 65 mmHg.
Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 70 mmHg.	From of anesthesia induction to end of wound closure.	TWA-MAP under 70 mmHg for each patient is derived by dividing area under the curve (AUC)-MAP under 70 mmHg by the time interval between the first and the last MAP measurements.
AUC-MAP under 70 mmHg.	From of anesthesia induction to end of wound closure.	AUC-MAP under 70 mmHg for each patient is derived by depth of hypotension in millimeters of mercury below a MAP of 70 mmHg × time in minutes spent below a MAP of 70 mmHg.
Duration of MAP under 70 mmHg.	From of anesthesia induction to end of wound closure.	Duration of MAP under 70 mmHg is the total amount of time in minutes that the MAP is under 70 mmHg.
Duration of MAP under 60 mmHg.	From of anesthesia induction to end of wound closure.	Duration of MAP under 60 mmHg is the total amount of time in minutes that the MAP is under 60 mmHg.
Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 60 mmHg.	From of anesthesia induction to end of wound closure.	TWA-MAP under 60 mmHg for each patient is derived by dividing area under the curve (AUC)-MAP under 60 mmHg by the time interval between the first and the last MAP measurements.
Postoperative complications.	From end of surgery to 30 days after surgery.	A composite of in-hospital all-cause mortality and cardiovascular, neurological, renal, respiratory, and infectious complications.
Days alive and at home.	From end of surgery to 30 days after surgery.	Number of days alive and at home within 30 days after surgery.
AUC-MAP under 60 mmHg.	From of anesthesia induction to end of wound closure.	AUC-MAP under 60 mmHg for each patient is derived by depth of hypotension in millimeters of mercury below a MAP of 60 mmHg × time in minutes spent below a MAP of 60 mmHg.
Postoperative quality of recovery.	At postoperative day 1.	Patient-reported quality of recovery after surgery and anesthesia with the QoR-15, ranging from 0 (poor recovery) to 150 (excellent recovery)

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, China