REmimazolam vs PrOpofol on Intraoperative hypotenSion in Major Noncardiac surgEry

NCT05436522 | Completed Phase 4

• 1 other identifier: NFEC-2021-260
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 65 mmHg.

  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.

  MAP measurements are recorded every minute from of anesthesia induction to end of wound closure.

Secondary Outcomes (11)

• AUC-MAP under 65 mmHg.

  From of anesthesia induction to end of wound closure.

• Duration of MAP under 65 mmHg.

  From of anesthesia induction to end of wound closure.

• Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 70 mmHg.

  From of anesthesia induction to end of wound closure.

• AUC-MAP under 70 mmHg.

  From of anesthesia induction to end of wound closure.

• Duration of MAP under 70 mmHg.

  From of anesthesia induction to end of wound closure.

Study Arms (2)

Remimazolam TIVA

EXPERIMENTAL

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

Drug: Remimazolam

Propofol TIVA

ACTIVE COMPARATOR

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

Drug: Propofol

Interventions

Remimazolam 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.

Remimazolam TIVA

Propofol 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.

Propofol TIVA

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, 510515, China

Location

MeSH Terms

Interventions

remimazolam; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: June 29, 2022
• Study Start: August 22, 2022
• Primary Completion: May 21, 2024
• Study Completion: June 21, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)