Pupillary Pain Index and Reaction to Skin Incision

• Sponsor: Pr Isabelle CONSTANT (Other)
• Overall Status: Completed
• CT.gov ID: NCT03103360
• Collaborator: (none)
• Enrollment: 53
• Location: 1
• Actual Duration (Months): 18
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Anesthesia; Surgery	Device: videopupillometer; Procedure: skin incision

Study Design

• Study Type: Observational
• Actual Enrollment: 53 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Actual Study Start Date: May 2, 2018
• Actual Primary Completion Date: Nov 2, 2019
• Actual Study Completion Date: Nov 2, 2019

Outcome Measures

Primary Outcome Measures

1. Relationship between pre-incision pupillary pain index and post-incision heart rate increase [4 minutes: one minute before incision, 3 minutes after incision]

2. Relationship between pre-incision pupillary pain index and post-incision blood pressure increase [4 minutes: one minute before incision, 3 minutes after incision]

3. Relationship between pre-incision pupillary pain index and post-incision bispectral index increase [4 minutes: one minute before incision, 3 minutes after incision]

4. Relationship between pre-incision pupillary pain index and post-incision movement occurrence [4 minutes: one minute before incision, 3 minutes after incision]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patient requiring general anesthesia

• surgical procedure involving a skin incision

• no regional anesthesia

• written informed consent

Exclusion Criteria:

• neurologic or ophthalmic disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Departement d'anesthesie Hopital Armand Trousseau	Paris		France	75012

Sponsors and Collaborators

• Pr Isabelle CONSTANT

Investigators

• Study Director: Isabelle Constant, MD-PHD, University Hospital Armand Trousseau

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pr Isabelle CONSTANT, Professor, Hôpital Armand Trousseau
• ClinicalTrials.gov Identifier: NCT03103360
• Other Study ID Numbers: PPI incision
• First Posted: Apr 6, 2017
• Last Update Posted: Mar 15, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Surgical Wound

Study Results

No Results Posted as of Mar 15, 2021