Bariatric Surgery, Obesity
Conditions
Keywords
Bariatric surgery, lidocaine, plasmatic concentration, MonoEthylGlycineXylidide (MEGx), safety
Brief summary
Intravenous lidocaine is efficient for management of post operative pain in abdominal surgery. As previously published in literature the investigators use it during bariatric surgery. Nevertheless plasmatic concentration of lidocaine is unknown in this population, despite a widespread use. Investigators propose in this work to bring an objective proof that administration of lidocaine based on a modified body weight is safe. Intravenous administration concerned the peri operative period. A total of six samples are taken for each patient. Investigators get approbation of local ethic committee for this work.
Interventions
BIOLOGICALBlood sampling
DRUGLidocaine
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 68 Years
Healthy volunteers
No
Inclusion criteria
* Adult who perform a bariatric surgery (sleeve, by-pass, mini by-pass) under laparoscopy * Body mass index \> = 40 kg/m2 * Informed consent signed * Patient treated with intravenous administration of lidocaine
Exclusion criteria
* Contraindication to lidocaine use (allergy, atrioventricular block, seizure, porphyria) * Concomitant use of beta blocker and others anti arrhythmic drugs * Cardiac or hepatic insufficiency * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasmatic concentration of lidocaine | From bolus to day 1 after cessation of administration | Blood samples will be removed by the peripheral catheter or direct venous puncture with other blood sample usually performed during post-operative period. First sample will be taken after initial bolus (ie 10 min after initiation of perfusion), second at 20 min, third at 30 min. The fourth and fifth samples will be taken after change of posology (from 2 to 1 mg/kg/h at the end of surgery) and at the end of administration. The sixth sample will be performed the day after the end of administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| occurence of adverse events related to lidocaine use | Up to 2 days after surgery | neurologic (seizure, dysgeusia, dizziness) or cardiologic events (atrio ventricular block, ventricular rhythm disorder) will be assessed after surgery, during hospitalization in post-operative room or intensive care unit. |
Countries
France
Outcome results
None listed