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REmimazolam vs PrOpofol on Intraoperative hypotenSion in Major Noncardiac surgEry (REPOSE-1)

Primary Purpose

Intraoperative Hypotension

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Remimazolam
Propofol
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraoperative Hypotension

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remimazolam TIVA

Propofol TIVA

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
Postoperative complications.
A composite of in-hospital all-cause mortality and cardiovascular, neurological, renal, respiratory, and infectious complications.
Days alive and at home.
Number of days alive and at home within 30 days after surgery.
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)

Full Information

First Posted
May 9, 2022
Last Updated
September 29, 2022
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05436522
Brief Title
REmimazolam vs PrOpofol on Intraoperative hypotenSion in Major Noncardiac surgEry
Acronym
REPOSE-1
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Hypotension

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remimazolam TIVA
Arm Type
Experimental
Arm Description
Induction: Remimazolam, sufentanil, cisatracurium. Maintenance: Remimazolam, remifentanil, cisatracurium.
Arm Title
Propofol TIVA
Arm Type
Active Comparator
Arm Description
Induction: Propofol, sufentanil, cisatracurium. Maintenance: Propofol, remifentanil, cisatracurium.
Intervention Type
Drug
Intervention Name(s)
Remimazolam
Intervention Description
Remimazolam is administered intravenously for induction and maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Propofol is administered intravenously for induction and maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60.
Primary Outcome Measure Information:
Title
Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 65 mmHg.
Description
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.
Time Frame
MAP measurements are recorded every minute from of anesthesia induction to end of wound closure.
Secondary Outcome Measure Information:
Title
AUC-MAP under 65 mmHg.
Description
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.
Time Frame
From of anesthesia induction to end of wound closure.
Title
Duration of MAP under 65 mmHg.
Description
Duration of MAP under 65 mmHg is the total amount of time in minutes that the MAP is under 65 mmHg.
Time Frame
From of anesthesia induction to end of wound closure.
Title
Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 70 mmHg.
Description
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.
Time Frame
From of anesthesia induction to end of wound closure.
Title
AUC-MAP under 70 mmHg.
Description
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.
Time Frame
From of anesthesia induction to end of wound closure.
Title
Duration of MAP under 70 mmHg.
Description
Duration of MAP under 70 mmHg is the total amount of time in minutes that the MAP is under 70 mmHg.
Time Frame
From of anesthesia induction to end of wound closure.
Title
Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 60 mmHg.
Description
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.
Time Frame
From of anesthesia induction to end of wound closure.
Title
AUC-MAP under 60 mmHg.
Description
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.
Time Frame
From of anesthesia induction to end of wound closure.
Title
Duration of MAP under 60 mmHg.
Description
Duration of MAP under 60 mmHg is the total amount of time in minutes that the MAP is under 60 mmHg.
Time Frame
From of anesthesia induction to end of wound closure.
Title
Postoperative complications.
Description
A composite of in-hospital all-cause mortality and cardiovascular, neurological, renal, respiratory, and infectious complications.
Time Frame
From end of surgery to 30 days after surgery.
Title
Days alive and at home.
Description
Number of days alive and at home within 30 days after surgery.
Time Frame
From end of surgery to 30 days after surgery.
Title
Postoperative quality of recovery.
Description
Patient-reported quality of recovery after surgery and anesthesia with the QoR-15, ranging from 0 (poor recovery) to 150 (excellent recovery)
Time Frame
At postoperative day 1.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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): 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bingcheng Zhao, MD
Phone
+8613763313653
Email
zhaobch@mail2.sysu.edu.cn
Facility Information:
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bingcheng Zhao, MD
Phone
+8613763313653
Email
zhaobch@mail2.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The deidentified IPD will be shared upon reasonable request after study completion.

Learn more about this trial

REmimazolam vs PrOpofol on Intraoperative hypotenSion in Major Noncardiac surgEry

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