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

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

Study Overview

• Status: Completed
• Conditions: Nociceptive Pain; Monitoring, Intraoperative
• Intervention / Treatment: Procedure: PDR measurement

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • University Hospital Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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: : 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; Other Names: PPI assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stimulation Intensity	Necessary stimulation intensity to dilate the pupil more than 13%	During perioperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Tachycardia as a common used parameter for perioperative nociceptive assessment	During PDR measurements
Pupillary Pain Index score	Device specific PPI score defined in accordance to stimulation intensity necessary for pupil dilation more than 13%	During perioperative period
Systolic blood pressure	Hypertension as a common used parameter for perioperative nociceptive assessment	During PDR measurements

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Investigators: Principal Investigator: Michiel Baeten, MD, University Hospital, Antwerp; Study Chair: Vera Saldien, MD, University Hospital, Antwerp; Principal Investigator: Natasja Peeters, MD, University Hospital, Antwerp

Publications and helpful links

Helpful Links

• Publication

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 7, 2017
• Primary Completion (ACTUAL): June 29, 2017
• Study Completion (ACTUAL): July 20, 2017

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (ACTUAL): May 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 16, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Pain; Neurologic Manifestations; Pupil Disorders; Nociceptive Pain; Mydriasis
• Other Study ID Numbers: 16/40/410-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No