Back to resultsEffect of Nociception Level Monitoring During Remimazolam-based Total Intravenous Anesthesia on Intraoperative Opioid Requirements and Postoperative Pain
Primary Purpose
Adult Patients Aged 19-64, Scheduled for Elective Arthroscopic Knee Surgery
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Analgesia Nociception Index monitor
Standard monitoring
Sponsored by
About this trial
This is an interventional other trial for Adult Patients Aged 19-64, Scheduled for Elective Arthroscopic Knee Surgery
Eligibility Criteria
Inclusion Criteria: Adult patients between 19 and 64 years of age, ASA class I~III, scheduled for arthroscopic knee surgeryunder general anesthesia. Exclusion Criteria: Patient refusal, patients unable to read consent form, active URI or uncontrolled asthma, pneumonia, history of allergies to benzodiazepines, decreased liver or kidney function, heart failure of ejection fraction<55%, pregnant or breastfeeding patients, history of substance abuse/addiction
Sites / Locations
- Yonsei University Health System, Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
ANI-guided
Standard
Arm Description
Patients receiving remimazolam-based total intravenous general anesthesia with nociception monitoring with the ANI monitor
Patients receiving remimazolam-based total intravenous general anesthesia based on hemodynamic variables and without ANI nociception monitoring
Outcomes
Primary Outcome Measures
Intraoperative remifentanil requirement
Intraoperative remifentanil requirements will be collected as primary outcome as µg/kg/min
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05615441
Brief Title
Effect of Nociception Level Monitoring During Remimazolam-based Total Intravenous Anesthesia on Intraoperative Opioid Requirements and Postoperative Pain
Official Title
Effect of Nociception Level Monitoring During Remimazolam-based Total Intravenous Anesthesia on Intraoperative Opioid Requirements and Postoperative Pain
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
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
This study aims to investigate whether the use of nociception monitoring during general anesthesia with remimazolam-based total intravenous anesthesia has an effect on intraoperative opioid requirements and postoperative pain. This study is a randomized trial with a 50% probability of being assigned to either group. Randomization will be done by an anesthesiologist not involved in anesthesia or postoperative outcome assessment. Patients and the investigator in charge of postoperative outcomes assessment will be blinded to group allocation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Patients Aged 19-64, Scheduled for Elective Arthroscopic Knee Surgery
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ANI-guided
Arm Type
Active Comparator
Arm Description
Patients receiving remimazolam-based total intravenous general anesthesia with nociception monitoring with the ANI monitor
Arm Title
Standard
Arm Type
Experimental
Arm Description
Patients receiving remimazolam-based total intravenous general anesthesia based on hemodynamic variables and without ANI nociception monitoring
Intervention Type
Device
Intervention Name(s)
Analgesia Nociception Index monitor
Intervention Description
Patients will receive remimazolam-based total intravenous general anesthesia with nociception monitoring with the ANI monitor
Intervention Type
Device
Intervention Name(s)
Standard monitoring
Intervention Description
Patients will receive remimazolam-based total intravenous general anesthesia based on hemodynamic monitoring and without nociception monitoring
Primary Outcome Measure Information:
Title
Intraoperative remifentanil requirement
Description
Intraoperative remifentanil requirements will be collected as primary outcome as µg/kg/min
Time Frame
Within the intraoperative period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients between 19 and 64 years of age, ASA class I~III, scheduled for arthroscopic knee surgeryunder general anesthesia.
Exclusion Criteria:
Patient refusal, patients unable to read consent form, active URI or uncontrolled asthma, pneumonia, history of allergies to benzodiazepines, decreased liver or kidney function, heart failure of ejection fraction<55%, pregnant or breastfeeding patients, history of substance abuse/addiction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seokyung Shin
Phone
82-2-2228-5785
Email
skshin@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seokyung Shin
Organizational Affiliation
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seokyung Shin
Phone
82-2-2228-5785
Email
skshin@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Nociception Level Monitoring During Remimazolam-based Total Intravenous Anesthesia on Intraoperative Opioid Requirements and Postoperative Pain
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