Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT05667987 En recrutement IDF

Titre

Evaluation of the Benefit of Lidocaine on the Prevention of the Risk of Post Endoscopic Retrograde Cholangio-pancreatography Pancreatitis. (PEPLID)

Type

Interventional

Pathologie

Pancréatite

Phase

N/A

Promoteur

GCS Ramsay Santé pour l'Enseignement et la Recherche (Voir sur ClinicalTrials)

Date de début

janvier 2024

Date de fin

avril 2026

Dernière mise à jour

02 juillet 2024

Résumé

The goal of this study is, in a population of patients undergoing ERCP surgery, treated preventively with NSAIDs and divided into two groups according to the absence (group 1) or presence (group 2) of intravenous lidocaine in the general anesthesia protocol. The main objective of this study is to compare the incidence of post-ERCP pancreatitis between the two groups. type of study: clinical trial participant population/health conditions: Patients with ERCP surgery

Détail

Voir le détail This is a single-center, prospective, randomized, single-blind study of two parallel groups of patients undergoing ERCP surgery - Group 1 (n=900): General anesthesia without IV lidocaine administration - Group 2 (n=900): General anesthesia with IV lidocaine administration Randomization Patients who have given written informed consent and received confirmation of eligibility will be randomized into the study according to a randomization list. According to the randomization, patients will be divided into two equal groups of 900 patients (anesthesia with and without lidocaine). The randomization list will be established by a centralized computer procedure. PAP prevention protocols Treatment with indomethacin (100mg intrarectally), which is the reference preventive treatment, will be administered systematically in both groups just before anesthesia (or during anesthesia if ERCP is preceded by an echo-endoscopy). The endoscopic techniques to prevent PAP (pancreatic prosthesis, double guide wire technique, infundibulotomy, needle pre-cutting ...) will be used by the operator according to his procedural habits and will be reported in the CRF. Anesthesia protocol All patients will be operated under general anesthesia with orotracheal intubation without premedication with the same anesthesia protocol: At induction: a hypnotic (propofol or hypnomidate) combined with a morphine (sufentanil or remifentanyl) and low doses of Ketamine and midazolam, with or without curarization. In maintenance phase sevoflurane. Blood pressure will be maintained by administration of ephedrine, neosynephrine or baby noradrenaline. The patient's hydration will be ensured by an infusion of Ringer Lactate (20ml/Kg). In the postoperative period, analgesic treatment will be systematically administered with, according to the needs, palliative analgesics 1 or 2 or morphine titration. Lidocaine administration protocol Patients randomized in group 2 will receive during anesthesia a treatment with 1% non-adrenalized Lidocaine. An initial bolus (1.5mg/kg) will be administered at induction of anesthesia (or upon ERCP decision if echo-endoscopy is in progress). Then IVSE of lidocaine at 2mg/Kg/hr will be started for one hour (to be continued in the ICU if needed). Fermer le détail

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
HOPITAL PRIVE DES PEUPLIERS	Gianfranco DONATELLI, MD	En recrutement IDF		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

- Patient over 18 years of age

- Patient who has read and signed the consent form for participation in the study

- Patient candidate for ERCP with virgin papilla

Critère de non inclusion

- Patient with sphincterotomized papilla

- Patient under court protection, guardianship or curatorship

- Pregnant woman or woman of childbearing age without highly effective contraception
for the duration of the study (surgically sterile, intrauterine device (> 14 days),
hormonal contraception (same dose and formulation for at least 6 months), sexual
abstinence. Women after menarche and until they become postmenopausal, unless they
are permanently infertile or have undergone surgical sterilization, are considered
to be of childbearing age, i.e. fertile. A postmenopausal condition is defined as
the absence of menstruation for 12 months without any other medical cause

- Patient not affiliated with the French social security system

- Patient participating in another clinical research protocol

- Impossibility to give the subject informed information and/or written informed
consent: dementia, psychosis, disorders of consciousness, non-French speaking
patient

- Contraindication to the use of NSAIDs

- Contraindication to anesthesia or to the administration of any of the products used
in anesthesia protocols (including lidocaine)

NCT05667987 - Evaluation of the Benefit of Lidocaine on the Prevention of the Risk of Post Endoscopic Retrograde Cholangio-pancreatography Pancreatitis. (PEPLID)

Informations générales
Etablissements
Critères
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