Oxidative Stress in the Patient With Peroperative Analgesia by Intravenous Lidocaine

NCT05562141 | Completed

• 1 other identifier: DR220194-OSPAIL
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Oxidative Stress; Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Reactive Oxygen Species

  24 hours after the start of the procedure

• Molecular antioxidant profile

  24 hours after the start of the procedure

Study Arms (2)

With lidocaine

Patient with injection of a 1.5 mg/kg bolus of lidocaine at induction of anaesthesia

Biological: Blood sample

Without lidocaine

Patient without injection of a 1.5 mg/kg bolus of lidocaine at induction of anaesthesia

Biological: Blood sample

Interventions

Blood sample BIOLOGICAL

Blood sample before induction, 1h after induction and 24h after the start of procedure

With lidocaine; Without lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient requiring urological or ENT surgery with arterial catheterisation

You may qualify if:

• Patients requiring urological or ear, nose \& throat (ENT) surgery with arterial catheterisation
• ASA 1 to 3
• ≥ 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

University hospital

Tours, 37044, France

Location

Related Publications (2)

• 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.

  PMID: 32886395 BACKGROUND

• 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.

  PMID: 31869414 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

3 blood samples before induction, 1 hour after the end of the induction at the time of the blood gas to adapt the ventilation and 24 hours from the start of the intervention

MeSH Terms

Conditions

Agnosia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 30, 2022
• Study Start: November 22, 2022
• Primary Completion: July 17, 2023
• Study Completion: July 18, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

FR (1)