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REPOSE-2: REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry

Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05728775
Collaborator
(none)
7,188
Enrollment
1
Location
2
Arms
58
Anticipated Duration (Months)
123.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this randomized controlled trial is to compare total intravenous anesthesia with remimazolam vs total intravenous anesthesia with propofol in moderate-to-high risk patients undergoing major elective noncardiac surgery under general anesthesia. The primary hypothesis is that total intravenous anesthesia with remimazolam can increase days alive and out of hospital at postoperative day 30 compared with total intravenous anesthesia with propofol.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
7188 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry (REPOSE-2): A Multicenter Randomized Controlled Trial
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Remimazolam TIVA

Remimazolam is administered at 6-12 mg/kg/h intravenously for anesthesia induction and at 1.0-2.0 mg/kg/h for maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60.

Drug: Remimazolam
Remimazolam is administered intravenously for induction and maintenance of general anesthesia.
Active Comparator: Propofol TIVA

Propofol 1.5-2.5mg/kg is administered intravenously for anesthesia induction and propofol at 4-12mg/kg/h is used for maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60.

Drug: Propofol
Propofol is administered intravenously for induction and maintenance of general anesthesia.

Outcome Measures

Primary Outcome Measures

  1. Days alive and out of hospital at day 30 [30 days after randomization]

    Number of days alive and out of hospital

Secondary Outcome Measures

  1. All-cause 30-day mortality [30 days after randomization]

    Number of patients who die of any cause

  2. Length of hospital stay [30 days after randomization]

    Number of days in hospital

  3. Unplanned re-hospitalization [30 days after randomization]

    Number of patients who experience unplanned hospital re-admissions

  4. Postoperative complications [30 days after randomization]

    Number of patients who experience postoperative complications

  5. Quality of Recovery-15 score on the first day after surgery [Postoperative day 1]

    Using Quality of Recovery-15 questionnaire to evaluate the quality of perioperative recovery. Quality of Recovery-15 consists of 15 comprehensive questions, including physical comfort (5 items), psychological support (2 items), physical independence (2 items), emotional state (4 items), and pain (2 items), each item is scored with 0-10 points, 0 represents poor state, 10 represents good state, and the total score is the Quality of Recovery-15 score of the patient.

Other Outcome Measures

  1. Cancer recurrence [3 years after randomization]

    Number of patients who experience cancer recurrence after radical resection of cancer

  2. All-cause 3-year mortality [3 years after randomization]

    Number of patients who die of any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age ≥45 years;

  • Undergoing elective major surgery under general anesthesia (expected surgery time >2 h, expected length of postoperative stay >2 d);

  • Fulfilling ≥1 of the following criteria:

  1. history of coronary artery disease;

  2. history of stroke;

  3. history of congestive heart failure;

  4. preoperative NT-proBNP >200 pg/mL or BNP>92 pg/mL;

  5. age ≥70 years;

  6. diabetes requiring medical treatment;

  7. ASA status 3 or 4;

  8. history of chronic kidney disease (preoperative sCr >133 μmol/L or 1.5 mg/dL);

  9. history of peripheral arterial disease;

  10. preoperative serum albumin <30 g/L;

  11. preoperative hemoglobin <100 g/L.

Exclusion Criteria:

  • Undergoing organ transplantation, cardiac, craniocerebral, burn or interventional operations;

  • Low risk or minor surgery

  • End-stage renal disease requiring renal-replacement therapy;

  • Hepatic dysfunction (Child B or C);

  • Previous liver or kidney transplantation;

  • Previous allergy to general anesthetics;

  • Unable to receive bispectral index monitoring;

  • ASA score ≥5;

  • Exposure to general anesthesia in prior 30 days;

  • Current participation in another interventional study;

  • Previous participation in this study;

  • Pregnant or breastfeeding women.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Southern Medical University Nanfang Hospital Guangzhou Guangdong China 510515

Sponsors and Collaborators

  • Nanfang Hospital of Southern Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT05728775
Other Study ID Numbers:
  • NFEC-2022-286
First Posted:
Feb 15, 2023
Last Update Posted:
Feb 15, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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:
Propofol

Study Results

No Results Posted as of Feb 15, 2023