ANI and Remifentanil in Skull Pin Fixation.
Primary Purpose
Pain, Procedural
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Remifentanil
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Procedural focused on measuring remifentanil, pain, analgesia nociception index
Eligibility Criteria
Inclusion Criteria:
- Must be at least 20 years old and less than 80 years old
- With anesthesia risk grade below grade three (including grade three) (ASA I~III)
- Patients who are expected to undergo intracranial surgery for skull pin fixation
Exclusion Criteria:
- Those with anesthesia risk classification ASA class IV or higher
- Those who are allergic to opioid analgesics or propofol drugs
- Emergency patients
Sites / Locations
- Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
neurosurgery with fixation
Arm Description
Outcomes
Primary Outcome Measures
50% effect concentration of remifentanil
50% effect concentration of remifentanil will be recorded at 2 mins before fixation, during fixation, 5mins after fixation, and 15 mins after fixation.
90% effect concentration of remifentanil
90% effect concentration of remifentanil will be recorded at 2 mins before fixation, during fixation, 5mins after fixation, and 15 mins after fixation.
Secondary Outcome Measures
Full Information
NCT ID
NCT05125328
First Posted
October 11, 2021
Last Updated
October 16, 2023
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05125328
Brief Title
ANI and Remifentanil in Skull Pin Fixation.
Official Title
To Explore the Optimal Dose of Remifentanil for Skull Pin Fixation in Intracranial Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2023 (Actual)
Primary Completion Date
June 12, 2023 (Actual)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Forty patients were enrolled, and all patients used total intravenous anesthesia (remifentanil-propofol based total intravenous analgesia) as anesthesia induction and maintenance. According to the preliminary data of this department, patients who underwent intracranial surgery for skull pin fixation used remifentanil 5.0-6.0 ng/ml, while the hemodynamics is relatively stable. Therefore, when this plan is implemented, the patient needs to be under the same depth of anesthesia (monitored by electroencephalography, maintaining a value of 40-60), first start with remifentanil 6.0 ng/ml, and use the up and down method as adjust 0.5 ng/ml of concentration of remifentanil each time. An Analgesia Nociception Index(ANI) lower than 30 and hyperdynamics (the increased heart rate(HR) and mean blood pressure(MBP) up 20% of baseline or HR>100bpm and arterial blood pressure(ABP)>180/100mmHg) indicates insufficient analgesia, therefore increase it by 0.5 ng/ml; an ANI higher than 30 and stable hemodynamics (the changes of HR and MBP within 20% of baseline or HR<50bpm and ABP<90/50mmHg) indicates that analgesia is acceptable, and the next patient will decrease it by 0.5 ng/ml during skull pin fixation.
Data collection: Heart Rate, Measure blood pressure, Analgesia Nociception Index, Bispectral index, concentrations of propofol and remifentanil before 2 mins, during, 5, and 15 mins of skull pin fixation were recorded and analyzed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Procedural
Keywords
remifentanil, pain, analgesia nociception index
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
neurosurgery with fixation
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
First start with remifentanil 6.0 ng/ml, and use the up and down method as adjust 0.5 ng/ml of concentration of remifentanil each time. An ANI lower than 30 and hyperdynamics (the increased heart rate and mean blood pressure up 20% of baseline or heart rate>100bpm and arterial blood pressure>180/100mmHg) indicates insufficient analgesia, therefore increase it by 0.5 ng/ml; an ANI higher than 30 and stable hemodynamics (the changes of HR and MBP within 20% of baseline or HR<50bpm and ABP<90/50mmHg) indicates that analgesia is acceptable, and the next patient will decrease it by 0.5 ng/ml during skull pin fixation.
Primary Outcome Measure Information:
Title
50% effect concentration of remifentanil
Description
50% effect concentration of remifentanil will be recorded at 2 mins before fixation, during fixation, 5mins after fixation, and 15 mins after fixation.
Time Frame
peri-fixation period
Title
90% effect concentration of remifentanil
Description
90% effect concentration of remifentanil will be recorded at 2 mins before fixation, during fixation, 5mins after fixation, and 15 mins after fixation.
Time Frame
peri-fixation period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be at least 20 years old and less than 80 years old
With anesthesia risk grade below grade three (including grade three) (ASA I~III)
Patients who are expected to undergo intracranial surgery for skull pin fixation
Exclusion Criteria:
Those with anesthesia risk classification ASA class IV or higher
Those who are allergic to opioid analgesics or propofol drugs
Emergency patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi-Fu Wu, MD
Phone
07-3121101
Ext
7035
Email
aneswu@gmail.com
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi-Fu Wu
12. IPD Sharing Statement
Learn more about this trial
ANI and Remifentanil in Skull Pin Fixation.
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