Clinical trial NCT05436522: REmimazolam vs PrOpofol on Intraoperative hypotenSion in Major Noncardiac surgEry
Official title: Effects of Total Intravenous Anesthesia With Remimazolam vs Propofol on Intraoperative Hypotension in Major Noncardiac Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intraoperative Hypotension
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 340
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 65 mmHg.
timeFrame: MAP measurements are recorded every minute from of anesthesia induction to end of wound closure.
Secondary outcomes:
measure: AUC-MAP under 65 mmHg.
timeFrame: From of anesthesia induction to end of wound closure.
measure: Duration of MAP under 65 mmHg.
timeFrame: From of anesthesia induction to end of wound closure.
measure: Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 70 mmHg.
timeFrame: From of anesthesia induction to end of wound closure.
measure: AUC-MAP under 70 mmHg.
timeFrame: From of anesthesia induction to end of wound closure.
measure: Duration of MAP under 70 mmHg.
timeFrame: From of anesthesia induction to end of wound closure.
measure: Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 60 mmHg.
timeFrame: From of anesthesia induction to end of wound closure.
measure: AUC-MAP under 60 mmHg.
timeFrame: From of anesthesia induction to end of wound closure.
measure: Duration of MAP under 60 mmHg.
timeFrame: From of anesthesia induction to end of wound closure.
measure: Postoperative complications.
timeFrame: From end of surgery to 30 days after surgery.
measure: Days alive and at home.
timeFrame: From end of surgery to 30 days after surgery.
measure: Postoperative quality of recovery.
timeFrame: At postoperative day 1.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
Study officials:
References: