In this study we want to evaluate effect of application of lidocaine spray vs. Normal saline spray before neonatal intubation on vagus stimulation(blood pressure,heart rate),oxygen saturation and time of intubation.
We conducted a randomized, double-blind, placebo-controlled during January 2014 to July 2014,include 60 neonates with gestational age more than30 week and exclude neonates less than 30 weeks then divided in two group. The Control group receive spray normal saline and intervention group receive spray lidocaine prior to intubation and blood pressure,heart rate,oxygen saturation and time was measured befor and after intubation and registered in questionnaires .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305188680N2
Registration date:2014-02-03, 1392/11/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-03, 1392/11/14
Registrant information
Name
Mirhadi Mussavi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3327 2094
Email address
mousavi-m@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Ilam University of Medical Sciences
Expected recruitment start date
2014-01-20, 1392/10/30
Expected recruitment end date
2014-07-20, 1393/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating application of lidocaine spray vs. Normal saline spray in preventing complications of neonatal intubation
Public title
Application of lidocaine in neonatal intubation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Neonate with GA more than 30 weeks ;without oropharyngeal anomaly and renal mass ;without congenital heart disease
Exclusion criteria :Neonates before 30weeks; neonates with renal mass or oropharyngeal anomaly ;neonates with congenital heart disease
Age
From 1 year old to 28 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ilam University of Medical Sciences
Street address
Banganjab
City
Ilam
Postal code
Approval date
2013-12-22, 1392/10/01
Ethics committee reference number
EC/92/h/157
Health conditions studied
1
Description of health condition studied
local Vagous nerve anesthesia
ICD-10 code
G52.2
ICD-10 code description
Disorders of vagus nerve
Primary outcomes
1
Description
heart rate
Timepoint
fefor and after intervention
Method of measurement
monitor bite/min
2
Description
blood pressure
Timepoint
befor and after intervention
Method of measurement
blood pressure monitor mmhg
3
Description
oxygen saturation
Timepoint
befor and after intervention
Method of measurement
pulsoxymeter mmhg
Secondary outcomes
1
Description
Intubation time
Timepoint
befor and after intervention
Method of measurement
cornometer secound
Intervention groups
1
Description
lidocain spray 1puff (3 mg/kg)before intubation
Category
Prevention
2
Description
Normal saline spray 1 puff before intervention
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU , Mustafa Khomeini Hospital, Ilam
Full name of responsible person
Dr.Mussavi,Hadi
Street address
Mustafa Khomeini Hospital, Ilam
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
drTaheri,Morovat
Street address
Banganjab
City
Ilam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr.Mussavi,MirHadi
Position
Assistant professor
Other areas of specialty/work
Street address
Mustafa Khomeini Hospital, Ilam, Iran
City
Ilam
Postal code
Phone
+98 84 1222 7120
Fax
Email
drmussavihadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr.Mussavi,MirHadi
Position
Assisstant proffessor
Other areas of specialty/work
Street address
Mustafa Khomeini Hospital, Ilam, Iran
City
Ilam
Postal code
Phone
+98 84 1222 7120
Fax
Email
drmussavihadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr.Mussavi,Mirhadi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 84 1222 7120
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)