Status:
COMPLETED
REmimazolam vs PrOpofol on Intraoperative hypotenSion in Major Noncardiac surgEry
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
Intraoperative Hypotension
Eligibility:
All Genders
45+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2024
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT05436522
Start Date
August 22 2022
End Date
June 21 2024
Last Update
February 6 2025
Active Locations (1)
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1
Nanfang Hospital, Southern Medical University
Guangzhou, China, 510515