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
NCT number | NCT03103360 |
Other study ID # | PPI incision |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2, 2018 |
Est. completion date | November 2, 2019 |
Verified date | March 2021 |
Source | Hôpital Armand Trousseau |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Departement d'anesthesie Hopital Armand Trousseau | Paris |
Lead Sponsor | Collaborator |
---|---|
Pr Isabelle CONSTANT |
France,
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 |
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