Pupillary Pain Index and Reaction to Skin Incision

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03103360

Enrollment

Registered

2017-04-06

Start date

2018-05-02

Completion date

2019-11-02

Last updated

2021-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Anesthesia, Surgery

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.

Interventions

DEVICEvideopupillometer

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

PROCEDUREskin incision

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 18 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

\- neurologic or ophthalmic disease

Design outcomes

Primary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026