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Pupillary Dilation Reflex (PDR) Evaluation During General Anesthesia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02942316
Enrollment
41
Registered
2016-10-24
Start date
2016-10-31
Completion date
2017-05-31
Last updated
2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Heart Rate, Reflex, Pupillary, Monitoring, Intraoperative

Brief summary

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

Detailed 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.

Interventions

DEVICEPupil 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

Sponsors

University Hospital, Antwerp
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pupillary Reflex DilationPerioperative phasePupillary Reflex Dilation is measured four times intraoperatively as a possible indicator of success of analgesia

Secondary

MeasureTime frameDescription
Patient MovementPerioperative phasePatient movement during surgery as a common used indicator for pain
Vital signsPerioperative phaseIncreased vital signs (heart rate, blood pressure) during surgery as a common used indicator for pain

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026