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

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ClinicalTrials.gov Identifier: NCT03140241
Recruitment Status : Completed
First Posted : May 4, 2017
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Davina Wildemeersch, University Hospital, Antwerp

Brief Summary:
After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively.

Condition or disease Intervention/treatment Phase
Nociceptive Pain Monitoring, Intraoperative Procedure: PDR measurement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pain Assessment by Pupil Dilation Reflex (PDR) and Pupillary Pain Index (PPI) in Response to Noxious Stimulation in Anesthetized Adults
Actual Study Start Date : May 7, 2017
Actual Primary Completion Date : June 29, 2017
Actual Study Completion Date : July 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: PDR measurement
Two measurements of PDR perioperatively before and after opioid administration
Procedure: PDR measurement

PDR measurement at two standardized times perioperatively:

  1. : anesthetized subject by propofol sedation until sedation depth monitor NeuroSense® (NeuroWave Systems Inc, Cleveland, OH) between 40-50
  2. : administration of remifentanil via effect site target concentration (Minto-model) at 5 ng/ml, in the absence of adjustments in sedation depth
Other Name: PPI assessment




Primary Outcome Measures :
  1. Stimulation Intensity [ Time Frame: During perioperative period ]
    Necessary stimulation intensity to dilate the pupil more than 13%


Secondary Outcome Measures :
  1. Pupillary Pain Index score [ Time Frame: During perioperative period ]
    Device specific PPI score defined in accordance to stimulation intensity necessary for pupil dilation more than 13%

  2. Systolic blood pressure [ Time Frame: During PDR measurements ]
    Hypertension as a common used parameter for perioperative nociceptive assessment

  3. Heart rate [ Time Frame: During PDR measurements ]
    Tachycardia as a common used parameter for perioperative nociceptive assessment



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140241


Locations
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Belgium
University hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
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Principal Investigator: Michiel Baeten, MD University Hospital, Antwerp
Principal Investigator: Natasja Peeters, MD University Hospital, Antwerp
Study Chair: Vera Saldien, MD University Hospital, Antwerp

Additional Information:
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Responsible Party: Davina Wildemeersch, MD, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03140241     History of Changes
Other Study ID Numbers: 16/40/410-2
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mydriasis
Nociceptive Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Pupil Disorders
Eye Diseases