Analgesia Clinical Trial
— OSPAILOfficial title:
Oxidative Stress in the Patient With Peroperative Analgesia by Intravenous Lidocaine
Verified date | January 2024 |
Source | University Hospital, Tours |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Depending on the anesthesiologist's habits, injection or not of a 1.5 mg/kg bolus of lidocaine at induction of anesthesia followed by a continuous infusion of 1.5 mg/kg/h. Additional blood sample at 3 different times without additional puncture compared to usual management: 1) during the placement of the venous line before induction (Reactive Oxygen Species), 2) 1h after the end of induction at the time of blood gas to adapt ventilation (Reactive Oxygen Species), 3) at 24h of the beginning of the intervention (Reactive Oxygen Species and antioxidant molecular profile).
Status | Completed |
Enrollment | 20 |
Est. completion date | July 18, 2023 |
Est. primary completion date | July 17, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients requiring urological or ear, nose & throat (ENT) surgery with arterial catheterisation - ASA 1 to 3 - = 18 years Exclusion Criteria: - Heart failure (NYHA = 3) - Liver failure (aspartate aminotransferase and/or alanine aminotransferase = 2N) - Chronic renal insufficiency (GFR = 30 ml/min/1.73m2) - Allergy or intolerance to lidocaine - Epilepsy - ASA 4 - Objection to data processing |
Country | Name | City | State |
---|---|---|---|
France | University hospital | Tours |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Tours |
France,
Picou F, Vignon C, Debeissat C, Lachot S, Kosmider O, Gallay N, Foucault A, Estienne MH, Ravalet N, Bene MC, Domenech J, Gyan E, Fontenay M, Herault O. Bone marrow oxidative stress and specific antioxidant signatures in myelodysplastic syndromes. Blood Adv. 2019 Dec 23;3(24):4271-4279. doi: 10.1182/bloodadvances.2019000677. — View Citation
Vignon C, Lachot S, Foucault A, Ravalet N, Gyan E, Picou F, Herault B, Le Nail LR, Bene MC, Herault O. Reactive oxygen species levels differentiate CD34+ human progenitors based on CD38 expression. Cytometry B Clin Cytom. 2020 Nov;98(6):516-521. doi: 10.1002/cyto.b.21948. Epub 2020 Sep 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reactive Oxygen Species | Analysis will be performed by flow cytometry using DCFDA labelling after erythrocyte lysis. Leukocyte subpopulations (lymphocytes, monocytes, polynuclears) will be identified by co-labelling with an anti-CD45 | 1 hour after induction | |
Secondary | Reactive Oxygen Species | Analysis will be performed by flow cytometry using DCFDA labelling after erythrocyte lysis. Leukocyte subpopulations (lymphocytes, monocytes, polynuclears) will be identified by co-labelling with an anti-CD45 | 24 hours after the start of the procedure | |
Secondary | Molecular antioxidant profile | The quantification of the expression of the 26 main antioxidant genes and their isoforms (antioxydogramTM ; patent WO2012085188 A1) will be performed on whole blood after RNA extraction, retrotranscription in cDNA. | 24 hours after the start of the procedure |
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