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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05436522
Recruitment Status : Not yet recruiting
First Posted : June 29, 2022
Last Update Posted : June 29, 2022
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

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.

Condition or disease Intervention/treatment Phase
Intraoperative Hypotension Drug: Remimazolam Drug: Propofol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Total Intravenous Anesthesia With Remimazolam vs Propofol on Intraoperative Hypotension in Major Noncardiac Surgery: a Randomized Controlled Trial
Estimated Study Start Date : July 2022
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arm Intervention/treatment
Experimental: Remimazolam TIVA
Induction: Remimazolam, sufentanil, cisatracurium. Maintenance: Remimazolam, remifentanil, cisatracurium.
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.

Active Comparator: Propofol TIVA
Induction: Propofol, sufentanil, cisatracurium. Maintenance: Propofol, remifentanil, cisatracurium.
Drug: 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.




Primary Outcome Measures :
  1. Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 65 mmHg. [ Time Frame: MAP measurements are recorded every minute from of anesthesia induction to end of wound closure. ]
    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 :
  1. AUC-MAP under 65 mmHg. [ Time Frame: From of anesthesia induction to end of wound closure. ]
    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.

  2. Duration of MAP under 65 mmHg. [ Time Frame: From of anesthesia induction to end of wound closure. ]
    Duration of MAP under 65 mmHg is the total amount of time in minutes that the MAP is under 65 mmHg.

  3. Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 70 mmHg. [ Time Frame: From of anesthesia induction to end of wound closure. ]
    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.

  4. AUC-MAP under 70 mmHg. [ Time Frame: From of anesthesia induction to end of wound closure. ]
    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.

  5. Duration of MAP under 70 mmHg. [ Time Frame: From of anesthesia induction to end of wound closure. ]
    Duration of MAP under 70 mmHg is the total amount of time in minutes that the MAP is under 70 mmHg.

  6. Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 60 mmHg. [ Time Frame: From of anesthesia induction to end of wound closure. ]
    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.

  7. AUC-MAP under 60 mmHg. [ Time Frame: From of anesthesia induction to end of wound closure. ]
    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.

  8. Duration of MAP under 60 mmHg. [ Time Frame: From of anesthesia induction to end of wound closure. ]
    Duration of MAP under 60 mmHg is the total amount of time in minutes that the MAP is under 60 mmHg.

  9. Postoperative complications. [ Time Frame: From end of surgery to 30 days after surgery. ]
    A composite of in-hospital all-cause mortality and cardiovascular, neurological, renal, respiratory, and infectious complications.

  10. Days alive and at home. [ Time Frame: From end of surgery to 30 days after surgery. ]
    Number of days alive and at home within 30 days after surgery.

  11. Postoperative quality of recovery. [ Time Frame: At postoperative day 5. ]
    Patient-reported quality of recovery after surgery and anesthesia with the QoR-15, ranging from 0 (poor recovery) to 150 (excellent recovery)



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05436522


Contacts
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Contact: Bingcheng Zhao, MD +8613763313653 zhaobch@mail2.sysu.edu.cn

Locations
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China
Nanfang Hospital, Southern Medical University
Guangzhou, China, 510515
Contact: Bingcheng Zhao, MD    +8613763313653    zhaobch@mail2.sysu.edu.cn   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
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Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT05436522    
Other Study ID Numbers: NFEC-2021-260
First Posted: June 29, 2022    Key Record Dates
Last Update Posted: June 29, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The deidentified IPD will be shared upon reasonable request after study completion.

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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
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics