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Remimazolam Total Intravenous Anesthesia Under Analgesia Nociception Index-guidance

Primary Purpose

Knee Osteoarthritis, Total Knee Arthroplasty, Remimazolam

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
remimazolam group
propofol group
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gangnam Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remimazolam group

Propofol group

Arm Description

Total intravenous anesthesia with remimazolam and remifentanil

Total intravenous anesthesia with propofol and remifentanil

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Postoperative opioid consumption
Postoperative opioid consumption

Full Information

First Posted
April 4, 2022
Last Updated
July 17, 2023
Sponsor
Gangnam Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05322902
Brief Title
Remimazolam Total Intravenous Anesthesia Under Analgesia Nociception Index-guidance
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 2, 2022 (Actual)
Primary Completion Date
July 10, 2023 (Actual)
Study Completion Date
July 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Total Knee Arthroplasty, Remimazolam

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remimazolam group
Arm Type
Experimental
Arm Description
Total intravenous anesthesia with remimazolam and remifentanil
Arm Title
Propofol group
Arm Type
Active Comparator
Arm Description
Total intravenous anesthesia with propofol and remifentanil
Intervention Type
Drug
Intervention Name(s)
remimazolam group
Intervention Description
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
Intervention Name(s)
propofol group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraoperative remifentanil consumption (mcg/kg/min)
Description
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.
Time Frame
Day 0, intraoperative
Secondary Outcome Measure Information:
Title
Numeric rating scale pain score at rest
Description
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.
Time Frame
up to 24 hours after the surgery
Title
Postoperative opioid consumption
Description
Postoperative opioid consumption
Time Frame
up to 24 hours after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 19~80 years of age who are expected to elective total knee arthroplasty under general anesthesia ASA PS 1-3 Exclusion Criteria: 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
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Remimazolam Total Intravenous Anesthesia Under Analgesia Nociception Index-guidance

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