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Pain Assessment by Pupil Dilation Reflex (PDR) and Pupillary Pain Index (PPI) in Response to Noxious Stimulation in Anesthetized Adults

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ClinicalTrials.gov Identifier: NCT03140241
Recruitment Status : Completed
First Posted : May 4, 2017
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Davina Wildemeersch, University Hospital, Antwerp

Tracking Information
First Submitted Date  ICMJE May 2, 2017
First Posted Date  ICMJE May 4, 2017
Last Update Posted Date May 21, 2018
Actual Study Start Date  ICMJE May 7, 2017
Actual Primary Completion Date June 29, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2017)
Stimulation Intensity [ Time Frame: During perioperative period ]
Necessary stimulation intensity to dilate the pupil more than 13%
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03140241 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2017)
  • Pupillary Pain Index score [ Time Frame: During perioperative period ]
    Device specific PPI score defined in accordance to stimulation intensity necessary for pupil dilation more than 13%
  • Systolic blood pressure [ Time Frame: During PDR measurements ]
    Hypertension as a common used parameter for perioperative nociceptive assessment
  • Heart rate [ Time Frame: During PDR measurements ]
    Tachycardia as a common used parameter for perioperative nociceptive assessment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain Assessment by Pupil Dilation Reflex (PDR) and Pupillary Pain Index (PPI) in Response to Noxious Stimulation in Anesthetized Adults
Official Title  ICMJE Pain Assessment by Pupil Dilation Reflex (PDR) and Pupillary Pain Index (PPI) in Response to Noxious Stimulation in Anesthetized Adults
Brief Summary After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively.
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Nociceptive Pain
  • Monitoring, Intraoperative
Intervention  ICMJE 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
Other Name: PPI assessment
Study Arms  ICMJE Experimental: PDR measurement
Two measurements of PDR perioperatively before and after opioid administration
Intervention: Procedure: PDR measurement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2017)
34
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2017)
32
Actual Study Completion Date  ICMJE July 20, 2017
Actual Primary Completion Date June 29, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Scheduled abdominal or gynecological surgery
  • 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 (DAF Guidelines)
  • Chronic opioid use (>3 months)
  • Ongoing treatment with beta-blockers, dopamine antagonists, topical atropine
  • Preoperatively administrated benzodiazepins or antiemetics
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03140241
Other Study ID Numbers  ICMJE 16/40/410-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Davina Wildemeersch, University Hospital, Antwerp
Study Sponsor  ICMJE University Hospital, Antwerp
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michiel Baeten, MD University Hospital, Antwerp
Principal Investigator: Natasja Peeters, MD University Hospital, Antwerp
Study Chair: Vera Saldien, MD University Hospital, Antwerp
PRS Account University Hospital, Antwerp
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP