Status:
COMPLETED
Pupillary Dilation Reflex Assessment for Intraoperative Analgesic Titration.
Lead Sponsor:
University Hospital, Antwerp
Collaborating Sponsors:
Universiteit Antwerpen
Conditions:
Pain, Acute
Anesthesia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this double blinded randomized controlled study, the pupillary dilation reflex is used for as a nociceptive indicator for opioid administration during elective 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, ca...
Eligibility Criteria
Inclusion
- \> 18 jaar
- Elective abdominal or gynaecological operation
- ASA (American Society of Anesthesiologists classification): I - II - III
Exclusion
- History of invasive ophthalmological surgery
- Known bilateral eye disease
- Known optical of oculomotor nerve deficit
- Active psychiatrical disease
- Proven active pheochromocytoma
- Opioid usage \> 7 days preoperative
- Ongoing oncological treatment with chemotherapeutic agents
- Usage of A-1 adrenergic of beta-blocking agents
- Preoperative usage of benzodiazepines
- Topical atropine or phenylephrine (eye droplets)
- Planned perioperative usage of dopamine antagonists
Key Trial Info
Start Date :
October 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03248908
Start Date
October 12 2017
End Date
January 31 2022
Last Update
May 15 2023
Active Locations (1)
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1
University hospital Antwerp
Edegem, Antwerp, Belgium, 2650