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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-07

Study Completion Date

2017-07-20

Brief Summary

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

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Detailed Description

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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.

Conditions

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Nociceptive Pain Monitoring, Intraoperative

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PDR measurement

Two measurements of PDR perioperatively before and after opioid administration

Group Type EXPERIMENTAL

PDR measurement

Intervention Type PROCEDURE

PDR measurement at two standardized times perioperatively:

1. : anesthetized subject by propofol sedation until sedation depth monitor NeuroSense® (NeuroWave Systems Inc, Cleveland, OH) between 40-50
2. : administration of remifentanil via effect site target concentration (Minto-model) at 5 ng/ml, in the absence of adjustments in sedation depth

Interventions

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PDR measurement

PDR measurement at two standardized times perioperatively:

1. : anesthetized subject by propofol sedation until sedation depth monitor NeuroSense® (NeuroWave Systems Inc, Cleveland, OH) between 40-50
2. : administration of remifentanil via effect site target concentration (Minto-model) at 5 ng/ml, in the absence of adjustments in sedation depth

Intervention Type PROCEDURE

Other Intervention Names

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PPI assessment

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No