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OpenTrials
Completed

NCT Number: NCT03103360

Pupillary Pain Index and Reaction to Skin Incision

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.

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Key information

Conditions

Pain Anesthesia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgery

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Departement d'anesthesie Hopital Armand Trousseau

Paris, 75012, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • neurologic or ophthalmic disease

Treatment and study plan

videopupillometer

Device

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

Skin incision

Procedure

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pr Isabelle CONSTANT

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 6, 2017
Registry last updated
Mar 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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