Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT03449732
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2018-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Pupil Dilation Reflex in Response to Noxious Stimulation in Anaesthetized Children. A Proof of Concept Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2018-02-22', 'studyFirstSubmitQcDate': '2018-02-27', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stimulation Intensity', 'timeFrame': 'During pupil measurements in the perioperative period', 'description': 'Necessary stimulation intensity to dilate the pupil more than 13%'}], 'secondaryOutcomes': [{'measure': 'Pupillary Pain Index score', 'timeFrame': 'During pupil measurements in the perioperative period', 'description': 'Device specific PPI score defined in accordance to stimulation intensity necessary for pupil dilation more than 13%'}, {'measure': 'Blood pressure', 'timeFrame': 'During PDR measurements', 'description': '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'}, {'measure': 'Heart rate', 'timeFrame': 'During PDR measurements', 'description': 'Tachycardia as a common used parameter for perioperative nociceptive assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Monitoring, Intraoperative']}, 'descriptionModule': {'briefSummary': 'After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively in infants, children and adolescents.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '28 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled abdominal, urological or otorhinolaryngology surgery under general anaesthesia\n* ASA I-II\n\nExclusion Criteria:\n\n* History of eye deformity, invasive ophthalmologic surgery\n* Known cranial nerve(s) deficit\n* Infection of the eye\n* Predicted difficult airway management (Paediatric Difficult Airway Guidelines - Difficult Airway Society)\n* Chronic opioid use (\\>3 months)\n* Ongoing treatment with beta-blockers, dopamine antagonists, topical atropine\n* Preoperatively administrated benzodiazepins or antiemetics'}, 'identificationModule': {'nctId': 'NCT03449732', 'acronym': 'Pain@OR-kids', 'briefTitle': 'Evaluation of the Pupil Dilation Reflex in Response to Noxious Stimulation in Anaesthetized Children. A Proof of Concept Trial', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '17/46/519'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PDR measurement group A', 'description': 'Two measurements of PDR perioperatively before and after opioid administration in toddlers (28 days until 23 months)', 'interventionNames': ['Device: PDR measurement']}, {'type': 'EXPERIMENTAL', 'label': 'PDR measurement group B', 'description': 'Two measurements of PDR perioperatively before and after opioid administration in children (2 until 11 years)', 'interventionNames': ['Device: PDR measurement']}, {'type': 'EXPERIMENTAL', 'label': 'PDR measurement group C', 'description': 'Two measurements of PDR perioperatively before and after opioid administration in adolescents (12 until 18 years)', 'interventionNames': ['Device: PDR measurement']}], 'interventions': [{'name': 'PDR measurement', 'type': 'DEVICE', 'otherNames': ['PPI assessment'], 'description': 'PDR measurement at two standardized times perioperatively:\n\n1. Anesthetized subject by sevoflurane sedation until a minimum alveolar concentration (MAC) of at least 1,5 is reached\n2. Administration of fentanyl 2µg/kg, in the absence of adjustments in sedation depth', 'armGroupLabels': ['PDR measurement group A', 'PDR measurement group B', 'PDR measurement group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'University hospital Antwerp', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}], 'overallOfficials': [{'name': 'Nathalie Kegels, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Antwerp'}, {'name': 'Vera Saldien, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Antwerp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Davina Wildemeersch', 'investigatorAffiliation': 'University Hospital, Antwerp'}}}}