OSPAIL: Oxidative Stress in the Patient With Peroperative Analgesia by Intravenous Lidocaine

Sponsor
University Hospital, Tours (Other)
Overall Status
Recruiting
CT.gov ID
NCT05562141
Collaborator
(none)
20
1
11.3
1.8

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Biological: Blood sample

Detailed 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)

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Oxidative Stress in the Patient With Peroperative Analgesia by Intravenous Lidocaine
Actual Study Start Date :
Nov 22, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
With lidocaine

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

Biological: Blood sample
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

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

Outcome Measures

Primary Outcome Measures

  1. Reactive Oxygen Species [1 hour after induction]

    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

Secondary Outcome Measures

  1. Reactive Oxygen Species [24 hours after the start of the procedure]

    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

  2. Molecular antioxidant profile [24 hours after the start of the procedure]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University hospital Tours France 37044

Sponsors and Collaborators

  • University Hospital, Tours

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT05562141
Other Study ID Numbers:
  • DR220194-OSPAIL
First Posted:
Sep 30, 2022
Last Update Posted:
Dec 30, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 30, 2022