Protocol summary

Summary
This study aimed at reducing the incidence of post-operative pulmonary edema in children undergoing patent ductus arteriosus ligation. The study is done randomly in two groups (120 patients are enrolled). In the intervention group, patient is given morphin and lasix after ligation of duct. The incidence of pulmonary edema in the intervention and control (without any intervention) group will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112098341N1
Registration date: 2012-11-10, 1391/08/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-11-10, 1391/08/20
Registrant information
Name
Ahmad Ebadi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3017
Email address
ebadi1959@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
1997-06-22, 1376/04/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the incidence of pulmonary edema using two methods of anesthesia in pediatrics undergoing patent ductus arteriosus (PDA) surgery
Public title
The comparison of the incidence of pulmonary edema using two methods of anesthesia in pediatrics undergoing PDA surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: isolated PDA patient aged 1_12 years; moderate and sever pulmonary HTN. Exclusion criteria: another structural abnormality.
Age
From 1 year old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan st.
City
Ahvaz
Postal code
Approval date
2011-11-12, 1390/08/21
Ethics committee reference number
eth-309

Health conditions studied

1

Description of health condition studied
patent ductus arteriosus
ICD-10 code
Q25.0
ICD-10 code description
Patent ductus arteriosus

Primary outcomes

1

Description
pulmonary edema
Timepoint
every 1 hour for 24 hr
Method of measurement
ausculation/ABG

Secondary outcomes

1

Description
Hypotension
Timepoint
each 15 min
Method of measurement
arterial line

Intervention groups

1

Description
Intervention group: morphin 0.1 mg/kg & lasix 0.5 mg/kg.
Category
Treatment - Drugs

2

Description
Control group: no drug
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Golestan hospital
Full name of responsible person
Dr Ahmad Ebadi, assistant professor
Street address
cardiosurgery operating room in Ahvaz Golestan hospital
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Mostafa Feghhi
Street address
Golestan blvd
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shohreh Beladi Behbahani
Position
anesthesiology assistant
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 1338 9329
Fax
Email
shohrehbeladi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Ahmad Ebadi
Position
assistan professor
Other areas of specialty/work
Street address
Golestan Hospital
City
Ahvaz
Postal code
Phone
+98 61 1336 1984
Fax
Email
ebadi1959@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shohreh Beladi Behbahani
Position
Anesthesiology assistant
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan blvd
City
Ahvaz
Postal code
Phone
Fax
Email
shohrehbeladi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...