An interventional study of PDR measurement in Nociceptive Pain and Monitoring, Intraoperative, sponsored by University Hospital, Antwerp. Completed at 1 site in Belgium. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-05-21.
Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Diagnostic
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After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively.
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.
96 studies on the registry are indexed under Nociceptive Pain; 18 are open to participants now.
This study's enrollment of 34 is below the median of 61 across 62 interventional studies indexed under Nociceptive Pain.
Browse Nociceptive Pain studies →University Hospital, Antwerp is the lead sponsor of 243 studies on the registry; 66 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two measurements of PDR perioperatively before and after opioid administration
Procedure: 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
Also known as: PPI assessment
Stimulation Intensity
Necessary stimulation intensity to dilate the pupil more than 13%
Time frame: During perioperative period
Pupillary Pain Index score
Device specific PPI score defined in accordance to stimulation intensity necessary for pupil dilation more than 13%
Time frame: During perioperative period
Systolic blood pressure
Hypertension as a common used parameter for perioperative nociceptive assessment
Time frame: During PDR measurements
Heart rate
Tachycardia as a common used parameter for perioperative nociceptive assessment
Time frame: During PDR measurements
Plan to share: No
Ran from May 2017 to primary completion in Jun 2017, 1 month.
Of 37 non-industry interventional studies with no phase under Nociceptive Pain, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 32. This study's 1 month is below that.
Counting every sponsor, half of 42 studies reached it within 8 months; a quarter within 3 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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