Comparison of Intraoperative Remifentanil Requirements During Remimazolam Versus Propofol Total Intravenous Anesthesia With Analgesia Nociception Index-guided Remifentanil Administration: a Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Gangnam Severance Hospital
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Intraoperative remifentanil consumption (mcg/kg/min)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients 19~80 years of age who are expected to elective total knee arthroplasty under general anesthesia
Exclusion Criteria
- •Second total knee arthroplasty under a prior plan of staged total knee arthroplasty, both
- •Previous hepatectomy or liver transplant
- •Estimated glomerular filtration rate < 30 mL/min/1.73m2
- •Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
- •Uncontrolled hypertension (systolic blood pressure > 160mmHg)
- •Acute narrow angle glaucoma
- •Myasthesia gravis
- •Known allergy to the drugs included in the study
- •Cardiac arrhthmia (non-sinus rhythm)
- •Taking drugs that affect the autonomic nervous system of diabetes
- •Psychiatric or neurologic disease (major depression disorder, dementia or cerebral infarction)
- •History of drug or alcohol abuse
Arms & Interventions
Remimazolam group
Total intravenous anesthesia with remimazolam and remifentanil
Intervention: remimazolam group (Drug)
Propofol group
Total intravenous anesthesia with propofol and remifentanil
Intervention: propofol group (Drug)
Outcomes
Primary Outcomes
Intraoperative remifentanil consumption (mcg/kg/min)
Time Frame: 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 Outcomes
- Numeric rating scale pain score at rest(up to 24 hours after the surgery)
- Postoperative opioid consumption(up to 24 hours after the surgery)
Investigators
Do-Hyeong Kim
Profeesor
Gangnam Severance Hospital