Foot and Ankle Fracture
Conditions
Interventions
Remimazolam group:Patients in the experimental group received remimazolam sedation during surgery.
Propofol group:Patients in the control group received propofol sedation during surgery.
Sponsors
Foshan Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 to 60 years; 2. Patients classified as ASA class I–II; 3. Patients undergoing foot and ankle fracture surgery; 4. Patients who fully understand the study, voluntarily participate, and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with known intolerance or allergy to remimazolam or propofol; 2. Patients with myasthenia gravis; 3. Patients with a history of psychiatric disorders; 4. Patients with a history of epilepsy; 5. Patients assessed as having difficult airway management; 6. Patients with cardiovascular diseases; 7. Patients with chronic renal failure or chronic liver impairment; 8. Patients with long-term alcohol or substance abuse; 9. Patients with lipodystrophy; 10. Patients with contraindications to neuraxial anesthesia; 11. Patients with a history of chronic lower limb pain; 12. Patients with a history of lower limb nerve injury; 13. Patients currently participating in other clinical trials; 14. Patients who refuse intraoperative sedation; 15. Patients deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative incidence of subclinical respiratory depression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative sedation depth;Incidence of intraoperative adverse reactions ;Patient awakening time;Quality of recovery (QoR-15) on the day before surgery and 24 hours postoperatively.; | — |
Countries
China
Contacts
Public ContactYuyuan You
Foshan Hospital of Traditional Chinese Medicine
Outcome results
None listed