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Evaluation of the Pupil Dilation Reflex in Response to Noxious Stimulation in Anaesthetized Children. A Proof of Concept Trial (Pain@OR-kids)

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ClinicalTrials.gov Identifier: NCT03449732
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Davina Wildemeersch, University Hospital, Antwerp

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

Condition or disease Intervention/treatment Phase
Pain Monitoring, Intraoperative Device: PDR measurement Not Applicable

Detailed 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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
Actual Study Start Date : March 30, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: PDR measurement group A
Two measurements of PDR perioperatively before and after opioid administration in toddlers (28 days until 23 months)
Device: PDR measurement

PDR measurement at two standardized times perioperatively:

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

Experimental: PDR measurement group B
Two measurements of PDR perioperatively before and after opioid administration in children (2 until 11 years)
Device: PDR measurement

PDR measurement at two standardized times perioperatively:

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

Experimental: PDR measurement group C
Two measurements of PDR perioperatively before and after opioid administration in adolescents (12 until 18 years)
Device: PDR measurement

PDR measurement at two standardized times perioperatively:

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




Primary Outcome Measures :
  1. Stimulation Intensity [ Time Frame: During pupil measurements in the perioperative period ]
    Necessary stimulation intensity to dilate the pupil more than 13%


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449732


Contacts
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Contact: Davina Wildemeersch, MD 38215891 ext 0032 davina.wildemeersch@uza.be
Contact: Guy Hans, MD, PhD 38213586 ext 0032 guy.hans@uza.be

Locations
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Belgium
University hospital Antwerp Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Davina Wildemeersch, MD    03 821 58 91 ext 0032    davina.wildemeersch@uza.be   
Contact: Guy Hans, MD,PhD    03 821 35 86    guy.hans@uza.be   
Principal Investigator: Davina Wildemeersch, MD         
Principal Investigator: Nathalie Kegels, MD         
Principal Investigator: Guy Hans, MD,PhD         
Sub-Investigator: Vera Saldien, MD         
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
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Principal Investigator: Nathalie Kegels, MD University Hospital, Antwerp
Study Chair: Vera Saldien, MD University Hospital, Antwerp

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Responsible Party: Davina Wildemeersch, Principle investigator, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03449732     History of Changes
Other Study ID Numbers: 17/46/519
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Mydriasis
Pupil Disorders
Eye Diseases