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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03103360
Other study ID # PPI incision
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2, 2018
Est. completion date November 2, 2019

Study information

Verified date March 2021
Source Hôpital Armand Trousseau
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date November 2, 2019
Est. primary completion date November 2, 2019
Accepts healthy volunteers No
Gender All
Age group 2 Years to 18 Years
Eligibility Inclusion Criteria: - patient requiring general anesthesia - surgical procedure involving a skin incision - no regional anesthesia - written informed consent Exclusion Criteria: - neurologic or ophthalmic disease

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France Departement d'anesthesie Hopital Armand Trousseau Paris

Sponsors (1)

Lead Sponsor Collaborator
Pr Isabelle CONSTANT

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relationship between pre-incision pupillary pain index and post-incision heart rate increase 4 minutes: one minute before incision, 3 minutes after incision
Primary Relationship between pre-incision pupillary pain index and post-incision blood pressure increase 4 minutes: one minute before incision, 3 minutes after incision
Primary Relationship between pre-incision pupillary pain index and post-incision bispectral index increase 4 minutes: one minute before incision, 3 minutes after incision
Primary Relationship between pre-incision pupillary pain index and post-incision movement occurrence 4 minutes: one minute before incision, 3 minutes after incision
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