Comparison of respiratory complication between intra-tracheal intubation and Laryngeal Mask Airway (LMA) in neonates undergoing general anesthesia for inguinal herniorrhaphy
This clinical trial is performed in Isfahan Imam Hossein (PBH) University Hospital from 21.3.2015 to 30.9.2016. Target population consists of 88 neonates who are candidates of unilateral inguinal herniorrhaphy. Exclusion criteria are surgical complication and operation cancelling.Random sampling will be done through Random Allocation II and patients will be allocated in two groups each consisting of 44 neonates. Intra-tracheal intubation will be performed in one group and Laryngeal Mask Airway(LMA) in the other. Anesthesia induction and maintenance will be performed similarly in both groups. Induction is administered by atropine (.02 mg/kg), fentanil 2µg /kg, atracorium (.5 mg/kg), and sodium Thiopental (5mg/kg). Isoflurane is administered for maintenance. SPO2 , CO2 and mean arterial pressure (MAP) will be registered every 15 minutes during operation. Respiratory complications (laryngospasm, bronchospasm ans cough) are registered and compared. Data will be analyzed by SPSS 22 through t-test and repeated measure ANOVA.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016070126866N2
Registration date:2016-07-11, 1395/04/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-11, 1395/04/21
Registrant information
Name
Amir Shafa
Name of organization / entity
Isfahan University of Medical Sciences, Imam hossein Hospital
Country
Iran (Islamic Republic of)
Phone
+98 31 3627 2655
Email address
amir_shafa@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University Of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-09-30, 1395/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of respiratory complication between intra-tracheal intubation and Laryngeal Mask Airway (LMA) in neonates undergoing general anesthesia for inguinal herniorrhaphy
Public title
respiratory complication in intra-tracheal intubation and Laryngeal Mask (LMA) in neonates
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: neonates (age one month and younger);body weight >3 kg; gestational age >34 weeks; ASA I class; candidate of unilateral inguinal herniorrhaphy
exclusion criteria:surgical complication, operation cancelled
Age
From 1 day old to 1 month old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences, ethical committee od deputy of reseach
Street address
gostaresh, hezarjerib ave.
City
Iisfahan
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
394063
Health conditions studied
1
Description of health condition studied
inguinal hernia
ICD-10 code
k40.9
ICD-10 code description
K40.9 Unilateral or unspecified inguinal hernia, without obstruction or gangrene
Primary outcomes
1
Description
respiratory complication
Timepoint
every 5 minutes during operation and every 15 minutes in recovery room
Method of measurement
SPO2, ETCO2, hemodynamic changes
Secondary outcomes
1
Description
Heart rate, mean arterial blood pressure (hemodynamic changes)
Timepoint
every 5 minutes during anesthesia and every 15 minutes in the recovery room
Method of measurement
S'adat monitoring device
Intervention groups
1
Description
Laryngeal Mask (LMA)
Category
Treatment - Drugs
2
Description
intra-tracheal intubation
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossin Hospital (PBUH), Isahan
Full name of responsible person
Amir Shafa, MD, anesthesiologist
Street address
Imam hossein Hospital, Imam khomeini ave, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Nematbakhsh
Street address
Isfahan faculty of medicine
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences, faculty of medicin
Full name of responsible person
Amir Shafa, MD
Position
assistant pofessor
Other areas of specialty/work
Street address
Imam Hossein (PBUH) children hospiotal, Imam khomeini ave.
City
Isfahan
Postal code
Phone
+31 36272655
Fax
Email
shafa_amir@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences, faculty of medicine
Full name of responsible person
Amir Shafa
Position
assistant professor
Other areas of specialty/work
Street address
Imam Hossein children hospital
City
Isfahan
Postal code
Phone
+36 272655
Fax
Email
shafa_amir@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences,faculty of medicine
Full name of responsible person
Amir Shafa
Position
Assistant
Other areas of specialty/work
Street address
Imam Hssein children hospital, imam khomeini ave.
City
Isfahan
Postal code
Phone
+36 272655
Fax
Email
shafa_amir@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)