NCT03103360

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 2, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2019

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

March 31, 2017

Last Update Submit

March 12, 2021

Conditions

PainAnesthesiaSurgery

Outcome Measures

Primary Outcomes (4)

  • Relationship between pre-incision pupillary pain index and post-incision heart rate increase

    4 minutes: one minute before incision, 3 minutes after incision

  • Relationship between pre-incision pupillary pain index and post-incision blood pressure increase

    4 minutes: one minute before incision, 3 minutes after incision

  • Relationship between pre-incision pupillary pain index and post-incision bispectral index increase

    4 minutes: one minute before incision, 3 minutes after incision

  • Relationship between pre-incision pupillary pain index and post-incision movement occurrence

    4 minutes: one minute before incision, 3 minutes after incision

Interventions

videopupillometerDEVICE

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

skin incisionPROCEDURE

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

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • \- neurologic or ophthalmic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement d'anesthesie Hopital Armand Trousseau

Paris, 75012, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Isabelle Constant, MD-PHD

    University Hospital Armand Trousseau

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 6, 2017

Study Start

May 2, 2018

Primary Completion

November 2, 2019

Study Completion

November 2, 2019

Last Updated

March 15, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)