Remimazolam Total Intravenous Anesthesia Under Analgesia Nociception Index-guidance

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05322902
• Other study ID #: 3-2022-0039
• Status: Completed
• Phase: N/A
• Start date: June 2, 2022
• Est. completion date: July 18, 2023

Study information

• Verified date: July 2023
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 18, 2023
• Est. primary completion date: July 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Remimazolam
• Total Knee Arthroplasty

Intervention

Drug:
• remimazolam group
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.
• propofol 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.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative remifentanil consumption (mcg/kg/min)	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.	Day 0, intraoperative
Secondary	Numeric rating scale pain score at rest	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.	up to 24 hours after the surgery
Secondary	Postoperative opioid consumption	Postoperative opioid consumption	up to 24 hours after the surgery