Spinal surgery
Conditions
Interventions
Trial Group:Remazolam target-controlled infusion (TCI), plasma concentration of 3 µg/ml during induction, adjustable to 4 µg/ml if necessary
target plasma concentration of 2-4 µg/mL during maintenance, combined with intravenous infusion of fentanyl citrate at 0.05-0.20 µg/kg/min
Control Group:Remazolam constant-rate infusion, 6 mg/kg/h continuous infusion for <=3 min during induction, be increased up to 12 mg/kg/h if needed
maintenance rate of 0.5-1.5 mg/kg/h, combined with intravenous infusion of fentanyl citrate at 0.05-0.20 µg/kg/min
Sponsors
The Second Affiliated Hospital of Inner Mongolia Medical University
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. ASA classification is I-III, aged between 60 and 80 years old, and BMI is between 19 and 30kg/m^2. 2. Patients who are scheduled to undergo spinal surgery in our hospital; 3. Be willing and able to abide by perioperative visit assessment, administration plan, laboratory tests and other clinical trial procedures.
Exclusion criteria
Exclusion criteria: 1. Allergic to or contraindicated to opioids, benzodiazepines and other drugs; 2. History of communication difficulties or long-term use of psychotropic drugs; 3. Predictable difficult airways; 4. The operation time is more than 5 hours or less than 1 hour; 5. Those with severe liver or kidney dysfunction and a history of alcohol abuse; 6. Those with severe circulatory dysfunction or abnormal coagulation mechanisms, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QoR-15 Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| General condition of the patient (age, gender, BMI, ASA classification and operation time, etc.;Heart Rate;Blood oxygen saturation;Mean Arterial Pressure;Bispectral Index;Time to Loss of Consciousness;Time to Emergence;Time to Extubation;Length of Stay in Recovery Room;Sedative Drug Usage;Analgesic Drug Usage;Muscle Relaxant Usage;Rescue Use of Vasopressors;Antagonist Usage;Injection Pain;Hypoxemia;Hypotension;Bradycardia;Nausea and Vomiting;Modified Observer's Assessment of Alertness/Sedation Score; | — |
Countries
China
Contacts
Public ContactWang Caixia
The Second Affiliated Hospital of Inner Mongolia Medical University
Outcome results
None listed