Acute Appendicitis Clinical Trial
Official title:
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
Verified date | October 2023 |
Source | Medical University of Warsaw |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 132 |
Est. completion date | August 8, 2023 |
Est. primary completion date | August 8, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Months to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Poland | University Clinic Centre of Medical University of Warsaw | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Medical University of Warsaw |
Poland,
El-Deeb A, El-Morsy GZ, Ghanem AAA, Elsharkawy AA, Elmetwally AS. The effects of intravenous lidocaine infusion on hospital stay after major abdominal pediatric surgery. A randomized double-blinded study. Egypt J Anaesth. 2013;29(3):225-230, doi: 10.1016/j.egja.2013.02.005.
Kaszynski M, Lewandowska D, Sawicki P, Wojcieszak P, Pagowska-Klimek I. Efficacy of intravenous lidocaine infusions for pain relief in children undergoing laparoscopic appendectomy: a randomized controlled trial. BMC Anesthesiol. 2021 Jan 5;21(1):2. doi: 10.1186/s12871-020-01218-0. — View Citation
Qi DY, Wang K, Zhang H, Du BX, Xu FY, Wang L, Zou Z, Shi XY. Efficacy of intravenous lidocaine versus placebo on attenuating cardiovascular response to laryngoscopy and tracheal intubation: a systematic review of randomized controlled trials. Minerva Anestesiol. 2013 Dec;79(12):1423-35. Epub 2013 Jul 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The requirement for opioids during anesthesia | Total amount of fentanyl in micrograms per kilogram body weight used during anesthesia. | From the induction of anesthesia through to postanesthesia care unit admission (10 minutes after extubation). | |
Primary | Hemodynamic reaction to tracheal intubation | A change in arterial blood pressure more than 20% from baseline. The fractions of patients in each group will be compared. | Before intubation - immediately after intubation. | |
Secondary | Metabolic response to laparoscopic procedure | Glucose [mg/dl] levels will be measured and compared before and after laparoscopic procedure. | First blood sample will be taken 5 minutes after tracheal intubation. Second blood sample will be taken just before extubation. | |
Secondary | Lidocaine blood level | Lidocaine level [mcg/ml] will be measured after initial bolus and just before the end of its infusion. | First blood sample will be taken 5 minutes after tracheal intubation. Second blood sample will be taken just before extubation. | |
Secondary | Side effects of lidocaine | Side effects of lidocaine will be assessed by recording the rates of the following complications: arrythmia, hypotension (defined as <70th percentile for age), allergic reaction. | From the beginning of drug infusion until transfer to the postanesthesia care unit (10 minutes after extubation). | |
Secondary | Hormonal response to laparoscopic procedure | Cortisol levels [mcg/dl] will be measured and compared before and after laparoscopic procedure. | First blood sample will be taken 5 minutes after tracheal intubation. Second blood sample will be taken just before extubation. |
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