Pupillary Pain Index and Reaction to Skin Incision

Completed

• Conditions: Surgery; Pain; Anesthesia

• Registration Number: NCT03103360
• Lead Sponsor: Pr Isabelle CONSTANT

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-31
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-06
• Study Start: 2018-05-02
• Primary Completion: 2019-11-02
• Study Completion: 2019-11-02
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-12
• Last Update Posted: 2021-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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
Relationship between pre-incision pupillary pain index and post-incision blood pressure increase	4 minutes: one minute before incision, 3 minutes after incision

Trial Locations

Locations (1)

Departement d'anesthesie Hopital Armand Trousseau; 🇫🇷 Paris, France