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Clinical Trials/NCT05322902
NCT05322902
Completed
N/A

Comparison of Intraoperative Remifentanil Requirements During Remimazolam Versus Propofol Total Intravenous Anesthesia With Analgesia Nociception Index-guided Remifentanil Administration: a Randomized Controlled Study

Gangnam Severance Hospital1 site in 1 country84 target enrollmentJune 2, 2022

Overview

Phase
N/A
Intervention
remimazolam group
Conditions
Knee Osteoarthritis
Sponsor
Gangnam Severance Hospital
Enrollment
84
Locations
1
Primary Endpoint
Intraoperative remifentanil consumption (mcg/kg/min)
Status
Completed
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
June 2, 2022
End Date
July 18, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Do-Hyeong Kim

Profeesor

Gangnam Severance Hospital

Eligibility Criteria

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

Arms & Interventions

Remimazolam group

Total intravenous anesthesia with remimazolam and remifentanil

Intervention: remimazolam group

Propofol group

Total intravenous anesthesia with propofol and remifentanil

Intervention: propofol group

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)

Study Sites (1)

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