Remimazolam Total Intravenous Anesthesia Under Analgesia Nociception Index-guidance

Y

Yonsei University Health System (YUHS)

Status

Completed

Conditions

Remimazolam
Knee Osteoarthritis
Total Knee Arthroplasty

Treatments

Drug: propofol group
Drug: remimazolam group

Study type

Interventional

Funder types

Other

Identifiers

NCT05322902
3-2022-0039

Details and patient eligibility

About

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.

Enrollment

84 patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

84 participants in 2 patient groups

Remimazolam group
Experimental group
Description:
Total intravenous anesthesia with remimazolam and remifentanil
Treatment:
Drug: remimazolam group
Propofol group
Active Comparator group
Description:
Total intravenous anesthesia with propofol and remifentanil
Treatment:
Drug: propofol group

Trial contacts and locations

1

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Central trial contact

Ji Yeong kim

Data sourced from clinicaltrials.gov

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