Remimazolam Total Intravenous Anesthesia Under Analgesia Nociception Index-guidance

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

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 Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Total Knee Arthroplasty; Remimazolam
• Intervention / Treatment: Drug: remimazolam group; Drug: propofol group

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam group; Total intravenous anesthesia with remimazolam and remifentanil	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.
Active Comparator: Propofol group; Total intravenous anesthesia with propofol and remifentanil	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Postoperative opioid consumption	Postoperative opioid consumption	up to 24 hours after the surgery

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Actual): July 10, 2023
• Study Completion (Actual): July 18, 2023

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: 3-2022-0039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No