The Effect of Intravenous Lidocaine Infusion on Hemodynamic Reaction to Tracheal Intubation, as Well as Metabolic and Hormonal Response to Laparoscopic Procedure in Children: a Randomized Controlled Trial

Lido02

Intravenous lidocaine - a potent local anesthetic with analgesic and anti- inflammatory properties has been shown to be an effective adjunct that reduces intra and postoperative opioid consumption and facilitates pain management in adults. In children population promising but limited evidence is available. The study has been planned to evaluate the efficacy of continuous intravenous infusion of lidocaine in alleviation of hemodynamic reaction to tracheal intubation, as well as metabolic and hormonal response to laparoscopic procedure in children.

2022-03-12

2023-08-08

2023-08-08

Completed

Early phase I

132

Inclusion Criteria: * ASA physical status class 1E, 2E, 3E; * Patients undergoing laparoscopic appendectomy. Exclusion Criteria: * Allergy to local anesthetics or contraindications for the use of lidocaine; * ASA physical status class 4E or higher; * Severe cardiovascular disease; * Preoperative bradycardia; * Preoperative atrioventricular block; * Renal failure; * Chronic treatment with analgesics; * Legal guardians' refusal.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'The drug or placebo(normal saline) will be placed in a syringe by the principal investigator. Only principal investigator will be aware of the participants allocation. The principal investigator will not be involved in the process of: recruitment, providing an intervention, or outcomes assessment.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 132, 'type': 'ACTUAL'}}

2023-10-31