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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03449732
Other study ID # 17/46/519
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 30, 2018
Est. completion date December 31, 2021

Study information

Verified date May 2022
Source University Hospital, Antwerp
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 31, 2021
Est. primary completion date April 26, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
PDR measurement
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

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 pupil measurements in the 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 pupil measurements in the perioperative period
Secondary Blood pressure 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 During PDR measurements
Secondary Heart rate Tachycardia as a common used parameter for perioperative nociceptive assessment During PDR measurements
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