REmimazolam vs PrOpofol on Intraoperative hypotenSion in Major Noncardiac surgEry

Intraoperative Hypotension Clinical Trial

— REPOSE-1  

Official title:

Effects of Total Intravenous Anesthesia With Remimazolam vs Propofol on Intraoperative Hypotension in Major Noncardiac Surgery: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05436522
• Other study ID #: NFEC-2021-260
• Status: Recruiting
• Phase: Phase 4
• Start date: August 22, 2022
• Est. completion date: August 2023

Study information

• Verified date: September 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: Bingcheng Zhao, MD
• Phone: +8613763313653
• Email: zhaobch[@]mail2.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: August 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension
• Intraoperative Hypotension

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	AUC-MAP under 65 mmHg.	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.	From of anesthesia induction to end of wound closure.
Secondary	Duration of MAP under 65 mmHg.	Duration of MAP under 65 mmHg is the total amount of time in minutes that the MAP is under 65 mmHg.	From of anesthesia induction to end of wound closure.
Secondary	Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 70 mmHg.	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.	From of anesthesia induction to end of wound closure.
Secondary	AUC-MAP under 70 mmHg.	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.	From of anesthesia induction to end of wound closure.
Secondary	Duration of MAP under 70 mmHg.	Duration of MAP under 70 mmHg is the total amount of time in minutes that the MAP is under 70 mmHg.	From of anesthesia induction to end of wound closure.
Secondary	Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 60 mmHg.	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.	From of anesthesia induction to end of wound closure.
Secondary	AUC-MAP under 60 mmHg.	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.	From of anesthesia induction to end of wound closure.
Secondary	Duration of MAP under 60 mmHg.	Duration of MAP under 60 mmHg is the total amount of time in minutes that the MAP is under 60 mmHg.	From of anesthesia induction to end of wound closure.
Secondary	Postoperative complications.	A composite of in-hospital all-cause mortality and cardiovascular, neurological, renal, respiratory, and infectious complications.	From end of surgery to 30 days after surgery.
Secondary	Days alive and at home.	Number of days alive and at home within 30 days after surgery.	From end of surgery to 30 days after surgery.
Secondary	Postoperative quality of recovery.	Patient-reported quality of recovery after surgery and anesthesia with the QoR-15, ranging from 0 (poor recovery) to 150 (excellent recovery)	At postoperative day 1.