Pupillary Pain Index and Reaction to Skin Incision

NCT ID: NCT03103360

Last Updated: 2021-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-02

Study Completion Date

2019-11-02

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Anesthesia Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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videopupillometer

Measure of pupillary diameter and pupillary pain index via an infrared camera Each measure lasts approximately 20 seconds

Intervention Type DEVICE

skin incision

performed under general anesthesia by the surgeon, at the beginning of an elective or emergency surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- neurologic or ophthalmic disease
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pr Isabelle CONSTANT

OTHER

Sponsor Role lead

Responsible Party

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Pr Isabelle CONSTANT

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Isabelle Constant, MD-PHD

Role: STUDY_DIRECTOR

University Hospital Armand Trousseau

Locations

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Departement d'anesthesie Hopital Armand Trousseau

Paris, , France

Site Status

Countries

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France

Other Identifiers

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PPI incision

Identifier Type: -

Identifier Source: org_study_id

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