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Clinical Trials/NCT03140241
NCT03140241
Completed
Not Applicable

Pain Assessment by Pupil Dilation Reflex (PDR) and Pupillary Pain Index (PPI) in Response to Noxious Stimulation in Anesthetized Adults

University Hospital, Antwerp1 site in 1 country34 target enrollmentMay 7, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nociceptive Pain
Sponsor
University Hospital, Antwerp
Enrollment
34
Locations
1
Primary Endpoint
Stimulation Intensity
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 7, 2017
End Date
July 20, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Davina Wildemeersch

MD

University Hospital, Antwerp

Eligibility Criteria

Inclusion Criteria

  • Scheduled abdominal or gynecological surgery

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

Outcomes

Primary Outcomes

Stimulation Intensity

Time Frame: During perioperative period

Necessary stimulation intensity to dilate the pupil more than 13%

Secondary Outcomes

  • Systolic blood pressure(During PDR measurements)
  • Pupillary Pain Index score(During perioperative period)
  • Heart rate(During PDR measurements)

Study Sites (1)

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