Remimazolam
DrugRemimazolam is administered intravenously for induction and maintenance of general anesthesia.
NCT Number: NCT05728775
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.
Interested in participating?
Request Info45 year and older
All sexes
Interventional
Phase 4
The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Remimazolam is administered intravenously for induction and maintenance of general anesthesia.
Propofol is administered intravenously for induction and maintenance of general anesthesia.
Time frame: 30 days after randomization
Number of days alive and out of hospital
Time frame: 30 days after randomization
Number of patients who die of any cause
Time frame: 30 days after randomization
Number of days in hospital
Time frame: 30 days after randomization
Number of patients who experience unplanned hospital re-admissions
Time frame: 30 days after randomization
Number of patients who experience postoperative complications
Time frame: 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.
Time frame: 3 years after randomization
Number of patients who experience cancer recurrence after radical resection of cancer
Time frame: 3 years after randomization
Number of patients who die of any cause
Contact information is provided by the study sponsor or research team.
Nanfang Hospital, Southern Medical University
Other
REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry (REPOSE-2): A Multicenter Randomized Controlled Trial
Acronym: REPOSE-2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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