Pupillary Pain Index and Reaction to Skin Incision

Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103360
• Other study ID #: PPI incision
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia
• Pain
• Surgery
• Surgical Wound

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