Remimazolam Total Intravenous Anesthesia Under Analgesia Nociception Index-guidance

NCT05322902 | Completed

• 1 other identifier: 3-2022-0039
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Arms (2)

Remimazolam group

EXPERIMENTAL

Total intravenous anesthesia with remimazolam and remifentanil

Drug: remimazolam group

Propofol group

ACTIVE COMPARATOR

Total intravenous anesthesia with propofol and remifentanil

Drug: propofol group

Interventions

remimazolam group 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.

Remimazolam group

propofol group 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.

Propofol group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 19\~80 years of age who are expected to elective total knee arthroplasty under general anesthesia
• ASA PS 1-3

You may not qualify if:

• 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
• Psychiatric or neurologic disease (major depression disorder, dementia or cerebral infarction)
• History of drug or alcohol abuse

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profeesor

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 12, 2022
• Study Start: June 2, 2022
• Primary Completion: July 10, 2023
• Study Completion: July 18, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)