Remimazolam Total Intravenous Anesthesia Under Analgesia Nociception Index-guidance

NCT ID: NCT05322902

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-02
• Study Completion Date: 2023-07-18

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.

Conditions

Knee Osteoarthritis; Total Knee Arthroplasty; Remimazolam

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Remimazolam group

Total intravenous anesthesia with remimazolam and remifentanil

Group Type: EXPERIMENTAL

remimazolam group

Intervention Type: DRUG

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

Total intravenous anesthesia with propofol and remifentanil

Group Type: ACTIVE_COMPARATOR

propofol group

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gangnam Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Do-Hyeong Kim

Profeesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gangnam Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

3-2022-0039

Identifier Type: -

Identifier Source: org_study_id