Back to resultsPain Assessment by Pupil Dilation Reflex (PDR) and Pupillary Pain Index (PPI) in Response to Noxious Stimulation in Anesthetized Adults
Primary Purpose
Nociceptive Pain, Monitoring, Intraoperative
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
PDR measurement
Sponsored by
About this trial
This is an interventional diagnostic trial for Nociceptive Pain
Eligibility Criteria
Inclusion Criteria:
- Scheduled abdominal or gynecological surgery
- ASA I-II
Exclusion Criteria:
- History of eye deformity, invasive ophthalmologic surgery
- Known cranial nerve(s) deficit
- Infection of the eye
- Predicted difficult airway management (DAF Guidelines)
- Chronic opioid use (>3 months)
- Ongoing treatment with beta-blockers, dopamine antagonists, topical atropine
- Preoperatively administrated benzodiazepins or antiemetics
Sites / Locations
- University hospital Antwerp
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PDR measurement
Arm Description
Two measurements of PDR perioperatively before and after opioid administration
Outcomes
Primary Outcome Measures
Stimulation Intensity
Necessary stimulation intensity to dilate the pupil more than 13%
Secondary Outcome Measures
Pupillary Pain Index score
Device specific PPI score defined in accordance to stimulation intensity necessary for pupil dilation more than 13%
Systolic blood pressure
Hypertension as a common used parameter for perioperative nociceptive assessment
Heart rate
Tachycardia as a common used parameter for perioperative nociceptive assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03140241
Brief Title
Pain Assessment by Pupil Dilation Reflex (PDR) and Pupillary Pain Index (PPI) in Response to Noxious Stimulation in Anesthetized Adults
Official Title
Pain Assessment by Pupil Dilation Reflex (PDR) and Pupillary Pain Index (PPI) in Response to Noxious Stimulation in Anesthetized Adults
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 7, 2017 (Actual)
Primary Completion Date
June 29, 2017 (Actual)
Study Completion Date
July 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp
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
After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively.
Detailed Description
An infrared camera of the video pupillometer measures the pupillary dilation reflex (PDR) in response to incremental nociceptive stimuli. The PDR is a robust reflex, even in patients under general anesthesia, and may provide a potential evaluation of the autonomous nociceptive circuit. American Society of Anesthesiologists (ASA) classification I or II patients undergoing elective surgery under general anesthesia are recruited. Enrolled patients perioperative undergo PDR measurement at 2 different standardized times (before and after opioid administration) generated by an inbuilt pupillary pain index (PPI) protocol. PPI, as a surrogate for nociception includes noxious stimulations from 10 up to 60 milli ampere (mA) until pupil dilation is larger than 13% from baseline diameter. Therefore, no inappropriate high stimulation is executed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nociceptive Pain, Monitoring, Intraoperative
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PDR measurement
Arm Type
Experimental
Arm Description
Two measurements of PDR perioperatively before and after opioid administration
Intervention Type
Procedure
Intervention Name(s)
PDR measurement
Other Intervention Name(s)
PPI assessment
Intervention Description
PDR measurement at two standardized times perioperatively:
: anesthetized subject by propofol sedation until sedation depth monitor NeuroSense® (NeuroWave Systems Inc, Cleveland, OH) between 40-50
: administration of remifentanil via effect site target concentration (Minto-model) at 5 ng/ml, in the absence of adjustments in sedation depth
Primary Outcome Measure Information:
Title
Stimulation Intensity
Description
Necessary stimulation intensity to dilate the pupil more than 13%
Time Frame
During perioperative period
Secondary Outcome Measure Information:
Title
Pupillary Pain Index score
Description
Device specific PPI score defined in accordance to stimulation intensity necessary for pupil dilation more than 13%
Time Frame
During perioperative period
Title
Systolic blood pressure
Description
Hypertension as a common used parameter for perioperative nociceptive assessment
Time Frame
During PDR measurements
Title
Heart rate
Description
Tachycardia as a common used parameter for perioperative nociceptive assessment
Time Frame
During PDR measurements
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Scheduled abdominal or gynecological surgery
ASA I-II
Exclusion Criteria:
History of eye deformity, invasive ophthalmologic surgery
Known cranial nerve(s) deficit
Infection of the eye
Predicted difficult airway management (DAF Guidelines)
Chronic opioid use (>3 months)
Ongoing treatment with beta-blockers, dopamine antagonists, topical atropine
Preoperatively administrated benzodiazepins or antiemetics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michiel Baeten, MD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Natasja Peeters, MD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vera Saldien, MD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Study Chair
Facility Information:
Facility Name
University hospital Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/29671874
Description
Publication
Learn more about this trial
Pain Assessment by Pupil Dilation Reflex (PDR) and Pupillary Pain Index (PPI) in Response to Noxious Stimulation in Anesthetized Adults
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