Remimazolam Total Intravenous Anesthesia Under Analgesia Nociception Index-guidance

• Sponsor: Gangnam Severance Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05322902
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 21.6
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis; Total Knee Arthroplasty; Remimazolam	Drug: remimazolam group; Drug: propofol group	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 2, 2022
• Anticipated Primary Completion Date: Mar 21, 2024
• Anticipated Study Completion Date: Mar 21, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. Postoperative opioid consumption [up to 24 hours after the surgery]

   Postoperative opioid consumption

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gangnam Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Do-Hyeong Kim, Profeesor, Gangnam Severance Hospital
• ClinicalTrials.gov Identifier: NCT05322902
• Other Study ID Numbers: 3-2022-0039
• First Posted: Apr 12, 2022
• Last Update Posted: Jun 16, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Propofol

Study Results

No Results Posted as of Jun 16, 2022