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Completed

NCT Number: NCT03449732

Evaluation of the Pupil Dilation Reflex in Response to Noxious Stimulation in Anaesthetized Children. A Proof of Concept Trial

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

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Key information

Conditions

Pain Monitoring, Intraoperative Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

28 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Antwerp

Edegem, Antwerp, 2650, Belgium

About this study

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 from the age of 28 days till 18 years 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled abdominal, urological or otorhinolaryngology surgery under general anaesthesia
  • 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 (Paediatric Difficult Airway Guidelines - Difficult Airway Society)
  • Chronic opioid use (>3 months)
  • Ongoing treatment with beta-blockers, dopamine antagonists, topical atropine
  • Preoperatively administrated benzodiazepins or antiemetics

Treatment and study plan

PDR measurement

Device

PDR measurement at two standardized times perioperatively:

  • Anesthetized subject by sevoflurane sedation until a minimum alveolar concentration (MAC) of at least 1,5 is reached
  • Administration of fentanyl 2µg/kg, in the absence of adjustments in sedation depth

Other names: PPI assessment

Primary outcomes

  1. Stimulation Intensity

    Time frame: During pupil measurements in the perioperative period

    Necessary stimulation intensity to dilate the pupil more than 13%

Secondary outcomes

  1. Pupillary Pain Index score

    Time frame: During pupil measurements in the perioperative period

    Device specific PPI score defined in accordance to stimulation intensity necessary for pupil dilation more than 13%

  2. Blood pressure

    Time frame: During PDR measurements

    Hypertension as a common used parameter for perioperative nociceptive assessment defined as an increase in systolic blood pressure by >10% of the initial systolic blood pressure

  3. Heart rate

    Time frame: During PDR measurements

    Tachycardia as a common used parameter for perioperative nociceptive assessment

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

Evaluation of the Pupil Dilation Reflex (PDR) Using a Pupillary Pain Index (PPI) Stimulation Protocol in Response to Noxious Stimulation in Anaesthetized Children. A Proof of Concept Trial

Acronym: Pain@OR-kids

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 28, 2018
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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