|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01387568 |
|
Date of registration:
|
29/06/2011 |
|
Primary sponsor: |
|
|
Public title:
|
Lidocaine Infusion for Major Abdominal Pediatric Surgery
|
|
Scientific title:
|
The Effects of Intravenous Lidocaine Infusion During and After Major Abdominal Pediatric Surgery. A Randomized Double-blinded Study |
|
Date of first enrolment:
|
March 2010 |
|
Target sample size:
|
80 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01387568 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
|
|
|
Countries of recruitment
|
|
Egypt
| | | | | | | |
|
Contacts
|
|
Name:
|
Alaa El Deep, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
alaaeldeep9@hotmail.com |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Pediatric
- Abdominal surgery
- ASA class I and II
Exclusion Criteria:
- history of hepatic diseases
- history of cardiac diseases
- history of renal diseases
- allergy to local anesthetics
- epilepsy
Age minimum:
1 Year
Age maximum:
6 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Elective Major Abdominal Surgery
|
|
Intervention(s)
|
|
Drug: Lidocaine Infusion
|
|
Drug: saline Infusion
|
|
Primary Outcome(s)
|
|
Blood pressure
[Time Frame: for 2hrs after infusion]
|
|
Secondary Outcome(s)
|
|
Heart rate (HR)
[Time Frame: for 6 hrs after infusion]
|
|
Pain scales
[Time Frame: 24 hrs postoperative]
|
|
Plasma Cortisol
[Time Frame: for 24 hrs after infusion]
|
|
Serum lidocaine
[Time Frame: 6 hrs after infusion]
|
|
Secondary ID(s)
|
|
MUH-AD-1-2011
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|