Frail Elderly
Conditions
Interventions
Remimazolam group:Induction and maintenance of anesthesia with Remimazolam.Group R? received IV remimazolam tosilate (0.2-0.3 mg/kg for induction
0.3-1.0 mg/kg/h for maintenance), sufentanil (0.3-0.5 µg/kg), rocuronium bromide (0.6 mg/kg) for induction, and remifentanil (8-15 µg/kg/h) for maintenance
Propofol group:Induction and maintenance of anesthesia with Propofol group.Group P? received intravenous propofol (1.0-1.5 mg/kg for induction
4-12 mg/kg/h for maintenance), sufentanil (0.3-0.5 µg/kg), rocuronium (0.6 mg/kg) for induction, and remifentanil (8-15 µg/kg/h) for maintenance.
Sponsors
The Second Hospital of Shanxi Medical University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Scheduled to undergo spinal surgery (cervical/thoracic/lumbar decompression and fusion surgery) under general anesthesia, with an expected duration>=1.5 hours; 2. Age>=60 years, and assessed as frail (Clinical Frailty Scale [CFS] >=4) within 7 days before surgery; 3.American Society of Anesthesiologists (ASA) physical status classification: II-III; 4.Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1.Communication barriers or severe cognitive impairment (e.g., baseline MoCA score <10 or known severe dementia) preventing completion of questionnaires; 2.Severe cardiac, pulmonary, hepatic, or renal insufficiency; 3.Known allergy to benzodiazepines, propofol, soy, or eggs; 4.Long-term use of benzodiazepines; 5.Anticipated difficult airway; 6.Uncorrected anemia (Hb <80 g/L) or thrombocytopenia (platelet count <80×10^9/L); 7.Scheduled for surgery requiring an intraoperative wake-up test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total QoR-15 score on postoperative day 3 (POD 3); | — |
Secondary
| Measure | Time frame |
|---|---|
| The QoR-15 dimension scores on postoperative day 3;Scores at 30 Days Postoperation: EQ-5D-5L and SF-12 V.2.0;Incidence of intraoperative hypotension;Incidence of delirium on postoperative day 3;Incidence of adverse events within 30 days after surgery; | — |
Countries
China
Contacts
Public ContactJi Jiawei
The Second Hospital of Shanxi Medical University
Outcome results
None listed