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Lidocaine VS Hemodynamic, Metabolic and Hormonal Response

Primary Purpose

Hemodynamic Response, Acute Appendicitis, Complication of Treatment

Status
Recruiting
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Intravenous lidocaine
Normal saline infusion
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemodynamic Response focused on measuring multimodal analgesia, lidocaine, intravenous lidocaine, laparoscopic appendectomy, children, pediatric population, adjuvant, metabolic stress response, hormonal response

Eligibility Criteria

18 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Clinic Centre of Medical University of WarsawRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine

Control

Arm Description

1% lidocaine intravenous bolus of 0.15 ml/kg over 5 min before induction of anesthesia followed by lidocaine infusion at 0.15 ml/kg/h intraoperatively will be administered. The infusion will be discontinued before the patients' transfer to the postanesthesia care unit.

0.9% NaCl intravenous bolus of 0.15 ml/kg over 5 min before induction of anesthesia followed by 0.9% NaCl infusion at 0.15 ml/kg/h intraoperatively will be administered. The infusion will be discontinued before the patients' transfer to the postanesthesia care unit.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Metabolic response to laparoscopic procedure
Glucose [mg/dl] levels will be measured and compared before and after laparoscopic procedure.
Lidocaine blood level
Lidocaine level [mcg/ml] will be measured after initial bolus and just before the end of its infusion.
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.
Hormonal response to laparoscopic procedure
Cortisol levels [mcg/dl] will be measured and compared before and after laparoscopic procedure.

Full Information

First Posted
January 21, 2022
Last Updated
April 25, 2023
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT05238506
Brief Title
Lidocaine VS Hemodynamic, Metabolic and Hormonal Response
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 12, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Laryngoscopy and endotracheal intubation are associated with noxious stimulation. Exacerbated circulatory system response may present as hypertension or arrhythmias including cardiac arrest. A sudden change in hemodynamic status connected with painful stimulation may precipitate deterioration in cerebral blood flow, especially in patients with intracranial hypertension (traumatic brain injury, intracranial hemorrhage, active hydrocephalus, etc). Many interventions have been applied to attenuate harmful hemodynamic reaction. One of them is intravenous lidocaine infusion. According to available data lidocaine is superior to placebo in attenuating systolic, diastolic and mean arterial pressure changes in children. Our study will focus on assessing hemodynamic stability preserving properties during induction of anesthesia and tracheal intubation. Blood pressure will be recorded and analyzed. The secondary aim is to examine intravenous lidocaine infusion in terms of reducing systemic response to surgical stress. Cortisol and glucose levels will be measured before skin incision, and immediately after the end of surgery. Side effects and serum lidocaine levels will be recorded to determine safety of the examined intervention. Similar pattern of infusion was investigated in RCT concerning children population - the toxic plasma level of 5 mcg/ml was not reached. Studies on children population have promising results but high quality randomized controlled trials are still missing. The proposed study has been planned to evaluate the efficacy of continuous infusion of lidocaine as an adjunct to standard general anesthesia (involving intravenous induction and opioid with sevoflurane maintenance) in attenuating hemodynamic reaction to tracheal intubation, as well as metabolic and hormonal response to surgical procedure in children undergoing laparoscopic appendectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodynamic Response, Acute Appendicitis, Complication of Treatment, Opioid Consumption, Pneumoperitoneum
Keywords
multimodal analgesia, lidocaine, intravenous lidocaine, laparoscopic appendectomy, children, pediatric population, adjuvant, metabolic stress response, hormonal response

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
1% lidocaine intravenous bolus of 0.15 ml/kg over 5 min before induction of anesthesia followed by lidocaine infusion at 0.15 ml/kg/h intraoperatively will be administered. The infusion will be discontinued before the patients' transfer to the postanesthesia care unit.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
0.9% NaCl intravenous bolus of 0.15 ml/kg over 5 min before induction of anesthesia followed by 0.9% NaCl infusion at 0.15 ml/kg/h intraoperatively will be administered. The infusion will be discontinued before the patients' transfer to the postanesthesia care unit.
Intervention Type
Drug
Intervention Name(s)
Intravenous lidocaine
Other Intervention Name(s)
IVL
Intervention Description
Intraoperative intravenous lidocaine infusion.
Intervention Type
Drug
Intervention Name(s)
Normal saline infusion
Other Intervention Name(s)
Placebo
Intervention Description
Intraoperative intravenous normal saline infusion.
Primary Outcome Measure Information:
Title
Hemodynamic reaction to tracheal intubation
Description
A change in arterial blood pressure more than 20% from baseline. The fractions of patients in each group will be compared.
Time Frame
Before intubation - immediately after intubation.
Secondary Outcome Measure Information:
Title
Metabolic response to laparoscopic procedure
Description
Glucose [mg/dl] levels will be measured and compared before and after laparoscopic procedure.
Time Frame
First blood sample will be taken 5 minutes after tracheal intubation. Second blood sample will be taken just before extubation.
Title
Lidocaine blood level
Description
Lidocaine level [mcg/ml] will be measured after initial bolus and just before the end of its infusion.
Time Frame
First blood sample will be taken 5 minutes after tracheal intubation. Second blood sample will be taken just before extubation.
Title
Side effects of lidocaine
Description
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.
Time Frame
From the beginning of drug infusion until transfer to the postanesthesia care unit (10 minutes after extubation).
Title
Hormonal response to laparoscopic procedure
Description
Cortisol levels [mcg/dl] will be measured and compared before and after laparoscopic procedure.
Time Frame
First blood sample will be taken 5 minutes after tracheal intubation. Second blood sample will be taken just before extubation.
Other Pre-specified Outcome Measures:
Title
The requirement for opioids during anesthesia
Description
Total amount of fentanyl in micrograms per kilogram body weight used during anesthesia.
Time Frame
From the induction of anesthesia through to postanesthesia care unit admission (10 minutes after extubation).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maciej Kaszyński
Phone
503018757
Ext
+48
Email
mkaszynski2@wum.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Izabela Pągowska-Klimek
Phone
607617796
Ext
+48
Email
izabela.pagowska-klimek@wum.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maciej Kaszyński
Organizational Affiliation
Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic Centre of Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
02-091
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maciej Kaszyński
Phone
503018757
Ext
+48
Email
mkaszynski2@wum.edu.pl
First Name & Middle Initial & Last Name & Degree
Izabela Pągowska-Klimek
Phone
607617796
Ext
+48
Email
izabela.pagowska-klimek@wum.edu.pl

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The datasets used and/or analysed during the study will be available from the corresponding author on reasonable request.
IPD Sharing Time Frame
The study protocol will be available to other researchers continuously after its publication. The CSR will be hopefully publicated after the study completion.
IPD Sharing Access Criteria
The datasets used and/or analysed during the study will be available from the corresponding author on reasonable request.
Citations:
PubMed Identifier
23839320
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
33397287
Citation
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.
Results Reference
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Lidocaine VS Hemodynamic, Metabolic and Hormonal Response

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