Oxidative Stress in the Patient With Peroperative Analgesia by Intravenous Lidocaine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-22

Study Completion Date

2023-07-18

Brief Summary

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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).

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Detailed Description

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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)

Conditions

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Oxidative Stress Analgesia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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With lidocaine

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

Blood sample

Intervention Type BIOLOGICAL

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

Without lidocaine

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

Blood sample

Intervention Type BIOLOGICAL

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

Interventions

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Blood sample

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No