Anesthesia, Surgery-Complications
Conditions
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.
Interventions
DRUGRemimazolam
Remimazolam is administered intravenously for induction and maintenance of general anesthesia.
DRUGPropofol
Propofol is administered intravenously for induction and maintenance of general anesthesia.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
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 or anticipated re-exposure to general anesthesia within 30 days after surgery; * Need for prolonged airway protection or mechanical ventilatory support after surgery; * Current participation in another interventional study; * Previous participation in this study; * Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days alive and out of hospital at day 30 | 30 days after randomization | Number of days alive and out of hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause 30-day mortality | 30 days after randomization | Number of patients who die of any cause |
| Length of hospital stay | 30 days after randomization | Number of days in hospital |
| Unplanned re-hospitalization | 30 days after randomization | Number of patients who experience unplanned hospital re-admissions |
| Postoperative complications | 30 days after randomization | Number of patients who experience postoperative complications |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Cancer recurrence | 3 years after randomization | Number of patients who experience cancer recurrence after radical resection of cancer |
| All-cause 3-year mortality | 3 years after randomization | Number of patients who die of any cause |
Countries
China
Contacts
Primary ContactBingcheng Zhao, MD
Outcome results
None listed