PainNCT02942316
Pupillary Dilation Reflex (PDR) Evaluation During General Anesthesia
A study testing Pupil dilation reflex measurement in people with Pain, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
In this study, the pupillary dilation reflex is measured as a nociceptive indicator during elective abdominal surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- Pupil dilation reflex measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled abdominal surgery
- ASA I-II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pupillary Dilation Reflex (PDR) Evaluation During General Anesthesia: a Pilot Study
In this study, the pupillary dilation reflex is measured as a nociceptive indicator during elective abdominal surgery under general anesthesia.
Read the 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.
- Conditions
- Pain
- Being tested
- Pupil dilation reflex measurement
- Keywords
- Heart Rate, Reflex, Pupillary, Monitoring, Intraoperative
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pupil dilation reflex measurementDevice
Pupillometry (PDR) at four standardized times perioperatively
- after induction, before opioid administration
- after opioid administration, steady state
- surgical incision
- end of procedure
| Study group | Role | What they receive |
|---|---|---|
| Pupil dilation reflex measurement | Experimental | Four measurements of PDR during surgery at standardized times Receives: Device: Pupil dilation reflex measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupillary Reflex Dilation
Pupillary Reflex Dilation is measured four times intraoperatively as a possible indicator of success of analgesia
Measured: Perioperative phase
Secondary outcomes (2)
Patient Movement
Patient movement during surgery as a common used indicator for pain
Measured: Perioperative phase
Vital signs
Increased vital signs (heart rate, blood pressure) during surgery as a common used indicator for pain
Measured: Perioperative phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionApr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davina Wildemeersch, University Hospital, Antwerp
- Investigators
- Robert Slappendel, MD, PhD, Study director, University Hospital, AntwerpMichiel Baeten, MD, Principal investigator, University Hospital, AntwerpDavina Wildemeersch, MD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942316
- Sponsor's protocol ID
- 16/40/410
- Status last verified
- May 2018
- First submitted
- 20 Oct 2016
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pupillary Dilation Reflex (PDR) Evaluation During General Anesthesia: a Pilot Study
- ClinicalTrials.gov ID
- NCT02942316
- Acronym / sponsor ID
- 16/40/410
- Conditions
- Pain
- Keywords
- Heart Rate, Reflex, Pupillary, Monitoring, Intraoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pupil dilation reflex measurement | Experimental | Device: Pupil dilation reflex measurementFour measurements of PDR during surgery at standardized times |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled abdominal surgery
- ASA I-II
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pupil dilation reflex measurementPupillometry (PDR) at four standardized times perioperatively * after induction, before opioid administration * after opioid administration, steady state * surgical incision * end of procedure | Device | Pupil dilation reflex measurement |
Primary outcome
Pupillary Reflex Dilation
Time frame: Perioperative phase
Pupillary Reflex Dilation is measured four times intraoperatively as a possible indicator of success of analgesia
2 secondary outcomes
Patient Movement
Time frame: Perioperative phase
Vital signs
Time frame: Perioperative phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
- PublicationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Slappendel, MD, PhD study director
University Hospital, Antwerp
Michiel Baeten, MD principal investigator
University Hospital, Antwerp
Davina Wildemeersch, MD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pupil dilation reflex measurement in people with Pain, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupillary Reflex Dilation (time frame: Perioperative phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018; AzTrials last refreshed its copy on 30 Oct 2026.