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Pupillary Pain Index and Reaction to Skin Incision

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ClinicalTrials.gov Identifier: NCT03103360
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Pr Isabelle CONSTANT, Hôpital Armand Trousseau

Brief Summary:
During routine general anesthesia (not standardized, left to the discretion of the attending anesthesiologist), pupillary pain index was measured one minute before skin incision. Then, variations in heart rate, blood pressure and bispectral index during the three minutes following skin incision were recorded, as well as the occurrence of movements.

Condition or disease Intervention/treatment
Pain Anesthesia Surgery Device: videopupillometer Procedure: skin incision

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Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Relationship Between the Pupillary Pain Index Measured One Minute Before Incision and the Motor, Hemodynamic and Electroencephalographic Reaction to Skin Incision in Patients Under General Anesthesia
Actual Study Start Date : May 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : May 2016

Intervention Details:
  • Device: videopupillometer
    Measure of pupillary diameter and pupillary pain index via an infrared camera Each measure lasts approximately 20 seconds
  • Procedure: skin incision
    performed under general anesthesia by the surgeon, at the beginning of an elective or emergency surgery.


Primary Outcome Measures :
  1. Relationship between pre-incision pupillary pain index and post-incision heart rate increase [ Time Frame: 4 minutes: one minute before incision, 3 minutes after incision ]
  2. Relationship between pre-incision pupillary pain index and post-incision blood pressure increase [ Time Frame: 4 minutes: one minute before incision, 3 minutes after incision ]
  3. Relationship between pre-incision pupillary pain index and post-incision bispectral index increase [ Time Frame: 4 minutes: one minute before incision, 3 minutes after incision ]
  4. Relationship between pre-incision pupillary pain index and post-incision movement occurrence [ Time Frame: 4 minutes: one minute before incision, 3 minutes after incision ]


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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children under general anesthesia for an elective or emergent surgery requiring a skin incision in a body area not covered by regional anesthesia
Criteria

Inclusion Criteria:

  • patient requiring general anesthesia
  • surgical procedure involving a skin incision
  • no regional anesthesia
  • written informed consent

Exclusion Criteria:

- neurologic or ophthalmic disease


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): NCT03103360


Locations
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France
Departement d'anesthesie Hopital Armand Trousseau
Paris, France, 75012
Sponsors and Collaborators
Pr Isabelle CONSTANT
Investigators
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Study Director: Isabelle Constant, MD-PHD University Hospital Armand Trousseau
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Responsible Party: Pr Isabelle CONSTANT, Professor, Hôpital Armand Trousseau
ClinicalTrials.gov Identifier: NCT03103360    
Other Study ID Numbers: PPI incision
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries