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

Nociceptive Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03140241
• Other study ID #: 16/40/410-2
• Status: Completed
• Phase: N/A
• Start date: May 7, 2017
• Est. completion date: July 20, 2017

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 20, 2017
• Est. primary completion date: June 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Monitoring, Intraoperative
• Mydriasis
• Nociceptive Pain

Intervention

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

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	Stimulation Intensity	Necessary stimulation intensity to dilate the pupil more than 13%	During perioperative period
Secondary	Pupillary Pain Index score	Device specific PPI score defined in accordance to stimulation intensity necessary for pupil dilation more than 13%	During perioperative period
Secondary	Systolic blood pressure	Hypertension as a common used parameter for perioperative nociceptive assessment	During PDR measurements
Secondary	Heart rate	Tachycardia as a common used parameter for perioperative nociceptive assessment	During PDR measurements

External Links

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