Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201410000871409 Date of Approval: 17/08/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intubation under sevoflurane anesthesia in neonates
Official scientific title Assessment of the intubating conditions during sevoflurane induction in neonates premedicated with nebulized lidocaine and fentanyl: A prospective double blind, placebo controlled, randomized study
Brief summary describing the background and objectives of the trial Summary Background: One of the important concerns during anesthesia of CDH repair is hypoxemia and hypotension caused by overdistention of the stomach and herniation across the midline which may occur as a result of positive pressure face mask ventilation during induction. Topical anesthesia to the airway may improve the intubating conditions during sevoflurane induction. In addition to its central effects, locally applied opioids elicit potent peripheral analgesic effects. Aim of the study: is to evaluate the effect of premedication by a combination of nebulized lidocaine and fentanyl on the intubating conditions without muscle relaxation during high inspired concentration of sevoflurane induction of anesthesia in neonates undergoing congenital diaphragmatic hernia repair. Patients and methods: Thirty patients of any gestational age ASA physical status II-III scheduled for congenital diaphragmatic hernia (CDH) will be randomly categorized using a computer-generated program to one of two groups undergoing induction of anesthesia with sevoflurane. ¿ Group A: nebulized solution contains 4 mg.kg-1 lidocaine 1 % plus 2 µg.kg-1 fentanyl. ¿ Group B (placebo): nebulized solution contains a comparable volume according to weight of normal saline 0.9 %. Anesthesia will be induced with 8 % sevoflurane in 100 % oxygen for 90 seconds using an appropriate sized facemask via a primed pediatric circle system. The proper sized endotracheal tube will then be inserted by Macintosh blade size 0 or Hemodynamics will be measured before nebulizer setting, before and after induction of anesthesia, immediately after intubation and every one minute after intubation for 5 minutes. Intubating conditions will be assessed using the Copenhagen scale. The number of intubation attempts and the duration of intubation (time between the initial introduction of the laryngoscope and fixation of the endotracheal tube) will be also assessed.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Anesthesia for congenital diaphragmatic hernia,Neonatal Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 03/08/2014
Actual trial start date 01/06/2014
Anticipated date of last follow up 28/12/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group nebulized lidocaine and fentanyl Once Till end of solution preoperative nebulized lidocaine and fentanyl followed by endotracheal intubation under sevoflurane anesthesia without face mask ventilation 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Thirty patients of any gestational age ASA physical status II-III scheduled for congenital diaphragmatic hernia (CDH) repair already intubated neonates, known or suspected neuromuscular disorders, history of opioid intake or infusion during the past three hours and finally anticipated difficult intubation in the form of known congenital airway anomalies. 0 Day(s) 3 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/02/2014 Alexandria Main University Hospitals
Ethics Committee Address
Street address City Postal code Country
Alsultan Hussein st Alexandria 21131 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome effect of premedication by a combination of nebulized lidocaine and fentanyl on the intubating conditions without muscle relaxation during high inspired concentration of sevoflurane induction of anesthesia in neonates undergoing congenital diaphragmatic hernia repair During intubation
Secondary Outcome Effect of the nebulized solution on hemodynamics Before, during and for 5 minutes following intubation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria main university hospitals Alsultan Hussein st Alexandria 21311 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self fund Alsultan Hussein St Alexandria 21311 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria Faculty of Medicine Alsultan Hussein St Alexandria 21131 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Moustafa Abdelaziz Moustafa Alexandria, Smouha, Alnasr st Alboroug Buildings, Building 5 Alexandria 21651 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moustafa Moustafa m.3abdelaziz@hotmail.com 00201222373407 Alexandria, Smouha, Alnasr st, Alboroug buildings, building 5
City Postal code Country Position/Affiliation
Alexandria 21651 Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Sanaa Morsi public.relations@alexmed.edu.eg 00201223926424 Alsultan Hussein
City Postal code Country Position/Affiliation
Alexandria 21131 Egypt Manager
Role Name Email Phone Street address
Scientific Enquiries Nagwa Elkobbia kobbia@yahoo.com +201223368233 Alsultan Hussein
City Postal code Country Position/Affiliation
Alexandria 21311 Egypt Professor of Anesthesia
REPORTING
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