Remimazolam Total Intravenous Anesthesia Under Analgesia Nociception Index-guidance

Not Applicable

Completed

• Conditions: Knee Osteoarthritis; Total Knee Arthroplasty; Remimazolam
• Interventions: Drug: propofol group; Drug: remimazolam group

• Registration Number: NCT05322902
• Lead Sponsor: Gangnam Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-04
• Study First Posted: 2022-04-12
• Study Start: 2022-06-02
• Status Verified: 2023-07
• Primary Completion: 2023-07-10
• Last Update Submitted: 2023-07-17
• Study Completion: 2023-07-18
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol group	propofol group	Total intravenous anesthesia with propofol and remifentanil
Remimazolam group	remimazolam group	Total intravenous anesthesia with remimazolam and remifentanil

Primary Outcome Measures

Name	Time	Method
Intraoperative remifentanil consumption (mcg/kg/min)	Day 0, intraoperative	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.

Secondary Outcome Measures

Name	Time	Method
Numeric rating scale pain score at rest	up to 24 hours after the surgery	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.
Postoperative opioid consumption	up to 24 hours after the surgery	Postoperative opioid consumption

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of