Pupillary Dilation Reflex (PDR) Evaluation During General Anesthesia

Pain Clinical Trial

Official title:

Pupillary Dilation Reflex (PDR) Evaluation During General Anesthesia: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02942316
• Other study ID #: 16/40/410
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2018
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the pupillary dilation reflex is measured as a nociceptive indicator during elective abdominal surgery under general anesthesia.

Description:

An infrared camera of the video pupillometer measures the pupillary dilation reflex (PDR) in response of a nociceptive stimulus. This autonomic reflex, parasympathetic mediated in sedated patients, can be generated by various pain stimuli (built in standardized protocol, surgical incision, …) The PDR is a robust reflex, even in patients under general anesthesia, and provides a potential evaluation of the autonomous circuit within the nociceptive evaluation based on pupil dilation upon A-delta and C fibers in both electrical or mechanic stimulation. This mono-centric project involving American Society of Anesthesiologists (ASA) classification I-II patients undergoing elective abdominal surgery under general anesthesia are recruited. Enrolled patients perioperative undergo PDR measurements at four different standardized times.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Scheduled abdominal surgery

• ASA I-II

Exclusion Criteria:

• History of eye deformity, invasive ophthalmologic surgery, impaired pupil reflex in advance

• Kown 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

Related Conditions & MeSH terms

• Mydriasis
• Pain

Intervention

Device:
• Pupil dilation reflex measurement
Pupillometry (PDR) at four standardized times perioperatively after induction, before opioid administration after opioid administration, steady state surgical incision end of procedure

Locations

Country	Name	City	State
Belgium	University hospital Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pupillary Reflex Dilation	Pupillary Reflex Dilation is measured four times intraoperatively as a possible indicator of success of analgesia	Perioperative phase
Secondary	Patient Movement	Patient movement during surgery as a common used indicator for pain	Perioperative phase
Secondary	Vital signs	Increased vital signs (heart rate, blood pressure) during surgery as a common used indicator for pain	Perioperative phase

External Links

•   Publication