Knee Osteoarthritis, Total Knee Arthroplasty, Remimazolam
Conditions
Brief summary
The investigators hypothesized that intraoperative opioid consumption would be different between remimazolam and propofol if the ANI-guided remifentanil continuous infusion rate was adjusted when the depth of anesthesia was maintained at similar depths with remimazolam or propofol under total intravenous anesthesia. The purpose of this study is to compare the intraoperative remifentanil requirement in patients undergoing total knee arthroplasty when the intraoperative remifentanil dose adjustment was performed under the ANI guidance while maintaining a similar depth of anesthesia with remimazolam or propofol.
Interventions
Remimazolam 6 mg/kg/hr is administered as an intravenous infusion until the patient loses consciousness. Anesthesia is maintained at 1 mg/kg/hr of remimazolam. After confirming that the eyelash reflex disappears, rocuronium 0.8 mg/kg is administered, and SGA insertion is performed. During maintenance of general anesthesia, the concentration of remifentanil is continuously adjusted so that the ANI is above 50.
DRUGpropofol group
Propofol intravenous infusion is initiated by the application of a target concentration infusion (TCI) pump to cause the patient to lose consciousness. After confirming that the eyelash reflex disappears, rocuronium 0.8 mg/kg is administered, and SGA insertion is performed. During maintenance of general anesthesia, the concentration of remifentanil is continuously adjusted so that the ANI is above 50.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients 19\ 80 years of age who are expected to elective total knee arthroplasty under general anesthesia 2. ASA PS 1-3
Exclusion criteria
1. Second total knee arthroplasty under a prior plan of staged total knee arthroplasty, both 2. Previous hepatectomy or liver transplant 3. Estimated glomerular filtration rate \< 30 mL/min/1.73m2 4. Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal) 5. Uncontrolled hypertension (systolic blood pressure \> 160mmHg) 6. Acute narrow angle glaucoma 7. Myasthesia gravis 8. Known allergy to the drugs included in the study 9. Cardiac arrhthmia (non-sinus rhythm) 10. Taking drugs that affect the autonomic nervous system of diabetes 11. Psychiatric or neurologic disease (major depression disorder, dementia or cerebral infarction) 12. History of drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative remifentanil consumption (mcg/kg/min) | Day 0, intraoperative | At the start of anesthesia induction, intravenous remifentanil infusion is started and the intraoperative remifentanil infusion rate is adjusted based on the ANI 50 during surgery. The total dose of remifentanil infused intraoperatively is recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric rating scale pain score at rest | up to 24 hours after the surgery | Pain intensity at rest will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) 1, 6, 24 hours after the surgery. |
| Postoperative opioid consumption | up to 24 hours after the surgery | Postoperative opioid consumption |
Countries
South Korea
Outcome results
None listed