Oxidative Stress in the Patient With Peroperative Analgesia by Intravenous Lidocaine

Analgesia Clinical Trial

— OSPAIL  

Official title:

Oxidative Stress in the Patient With Peroperative Analgesia by Intravenous Lidocaine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05562141
• Other study ID #: DR220194-OSPAIL
• Status: Completed
• Start date: November 22, 2022
• Est. completion date: July 18, 2023

Study information

• Verified date: January 2024
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

Intraoperatively, depending on the habits of the anesthesiologist, lidocaine may be started after induction (bolus of 1.5 mg/kg then relay at 1.5 mg/kg/h until the end of the procedure) or not (control group).

Three blood samples will be taken. The first one (T0) during the placement of the venous line before induction and the second one (T1) one hour after the end of induction when the blood gas on the arterial catheter is taken to adapt the ventilation. These samples will be taken by the nurse in charge of the patient during the procedure. The third sample (T24) will be taken 24 hours after the beginning of the operation, during the blood test (venous or arterial), by the nurse of the department where the patient will be hospitalized. These samples will allow the evaluation of the level of Reactive Oxygen Species (ROS) (T0, T1, T24

• 4ml dry tube) and the antioxidant molecular profile (T24 - same tube as for the evaluation of the ROS (Reactive Oxygen Species) level). The collection of patient data will stop at D1 after the sampling.

The anesthesia protocol will be standardized, in accordance with the department's habits and respecting the recommendations of the French Society of Anaesthesia and Intensive Care (SFAR): patient monitoring (pulse oximeter, invasive arterial catheter, capnograph, curarimeter and sevoflurane concentration monitoring), pre-oxygenation, intravenous induction (propofol, sufentanil, atracurium or rocuronium - dose at the discretion of the anesthesiologist), and maintenance with sevoflurane Intraoperative analgesia will systematically include the injection of sufentanil as well as at the end of the surgery the administration of paracetamol (1g) and nefopam (20 mg) associated or not with an anti-inflammatory. After induction, a dose of 8 mg of dexamethasone will be administered to the patient for the prevention of postoperative nausea and vomiting. In the recovery room, morphine titration can be performed if Visual Analogue Scale (VAS)>3 (3mg/5min). The postoperative analgesia protocol will be left to the discretion of the anesthesiologist.

The parameters collected will be the demographic characteristics (sex, age, weight, height), the terrain (ASA score), the results of the preoperative biological examination (blood ionogram, urea, creatinine, blood count, liver examination), the duration of anesthesia and the doses of drugs received intraoperatively. The parameters measured will be the level of Reactive Oxygen Species in the blood sub populations and the antioxidant molecular profile:

Reactive Oxygen Species :

Analysis will be performed by flow cytometry using DCFDA labeling after erythrocyte lysis. Leukocyte sub populations (lymphocytes, monocytes, polynuclears) will be identified by co-labeling with an anti-Cluster Differentiation 45 antibody (anti-CD45).

Antioxidant molecular profile :

Quantification of the expression of the 26 major antioxidant genes and their isoforms (antioxidogramTM; patent WO2012085188 A1) will be performed on whole blood after RNA extraction, retro transcription into deoxyribonucleic acid (cDNA)

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Analgesia
• Oxidative Stress

Intervention

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

Locations

Country	Name	City	State
France	University hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

References & Publications (2)

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

Outcome

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