Pupillary Pain Index and Reaction to Skin Incision

March 12, 2021 updated by: Pr Isabelle CONSTANT

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • Departement d'anesthesie Hopital Armand Trousseau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 minutes: one minute before incision, 3 minutes after incision
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
4 minutes: one minute before incision, 3 minutes after incision
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 minutes: one minute before incision, 3 minutes after incision
Relationship between pre-incision pupillary pain index and post-incision movement occurrence
Time Frame: 4 minutes: one minute before incision, 3 minutes after incision
4 minutes: one minute before incision, 3 minutes after incision

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pr Isabelle CONSTANT

Investigators

  • Study Director: Isabelle Constant, MD-PHD, University Hospital Armand Trousseau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2018

Primary Completion (Actual)

November 2, 2019

Study Completion (Actual)

November 2, 2019

Study Registration Dates

First Submitted

March 31, 2017

First Submitted That Met QC Criteria

March 31, 2017

First Posted (Actual)

April 6, 2017

Study Record Updates

Last Update Posted (Actual)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 12, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPI incision

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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