Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery
Information source: Hospices Civils de Lyon
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity; Bariatric Surgery
Intervention: Blood sampling (Biological); Lidocaine (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Hospices Civils de Lyon Overall contact:
Thomas RIMMELE, MD, PhD, Phone: +33 4 72 11 02 81, Email: thomas.rimmele@chu-lyon.fr
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.
Clinical Details
Official title: Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Plasmatic concentration of lidocaine
Secondary outcome: occurence of adverse events related to lidocaine use
Eligibility
Minimum age: 18 Years.
Maximum age: 68 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Thomas RIMMELE, MD, PhD, Phone: +33 4 72 11 02 81, Email: thomas.rimmele@chu-lyon.fr
Hôpital Edouard Herriot - Département d'anesthésie réanimation, LYON cedex 03 69437, France; Not yet recruiting
Thomas RIMMELE, MD, PhD, Phone: +33 4 72 11 02 81, Email: thomas.rimmele@chu-lyon.fr
Benjamin DELWARDE, MD, PhD, Phone: +33 4 72 11 62 76, Email: benjamin.delwarde@chu-lyon.fr
Thomas RIMMELE, MD, PhD, Principal Investigator
Benjamin DELWARDE, MD, PhD, Sub-Investigator
Additional Information
Starting date: August 2015
Last updated: August 13, 2015
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