This study aim was to evaluate the effect of isosorbide dinitrate in the prevention of severe preeclampsia in patients with mild preeclampsia. Twenty seven women with single tone pregnancy with gestational age of 36-26 weeks and the diagnosis of mild preeclampsia were enrolled in the study and were assigned into intervention or control groups. Intervention group received 10 mg of isosorbide dinitrate oral tablet three times a day and the control group received no treatment. Delay in symptoms of severe preeclampsia and gestation duration in both groups were measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706041083N1
Registration date:2007-07-01, 1386/04/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2007-07-01, 1386/04/10
Registrant information
Name
Majid Pourshaikhian
Name of organization / entity
Guilan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 13 3360 5768
Email address
m_pourshaikhan@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University Medical Sciences and Health Services
Expected recruitment start date
2007-07-01, 1386/04/10
Expected recruitment end date
2008-07-10, 1387/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Dexamethasone and Doxapram in Prevention of post-anesthetic shivering, in 2008
Public title
Prevention of post-anesthetic shivering with drugs
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 25-70 years old, ASA Class I & II, under elective abdominal & chest surgery, under General anesthesia,
Exclusion criteria: presence of co-existing peptic ulcer, convulsive disease, immunodeficiency, fever (T>38), muscular disease, asthma, hypersensitivity to dexametasone or doxapram, Low temperature of OR & PACU (<20), patient’s dissatisfaction
Age
From 25 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Guilan University of Medical Sciences and Health Services
Street address
Vice-chancellor for Research, Guilan University of Medical Sciences and Health Services, Shahid Siadatai Ave., Namjoo street, Rasht
City
Rasht
Postal code
41469-68164
Approval date
2009-02-03, 1387/11/15
Ethics committee reference number
5237 /132/3/پ
Health conditions studied
1
Description of health condition studied
General anesthesia
ICD-10 code
T88.8
ICD-10 code description
Complications of surgical and medical care, not elsewhere classified
Primary outcomes
1
Description
Shivering
Timepoint
30 minutes after intervention
Method of measurement
observation of shivering of muscles of trunk & pectoralis
Secondary outcomes
1
Description
nausea & vomiting
Timepoint
30-60 minutes after intervention
Method of measurement
direct observation
2
Description
Respiratory stimulus
Timepoint
30-60 minutes after intervention
Method of measurement
Direct observation
3
Description
Restlessness
Timepoint
30-60 minutes after intervention
Method of measurement
Direct observation
4
Description
cough
Timepoint
30-60 minutes after intervention
Method of measurement
direct observation
Intervention groups
1
Description
Amp Dexamethasone 0.1 mg/kg, IV, 10 minutes before extubation, stat.
Category
Treatment - Drugs
2
Description
AMP Doxapram 0.75 mg/kg, IV, 10 minutes before extubation, stat dose
Category
Treatment - Drugs
3
Description
3 ml of distilled water, IV, 10 minutes before extubation, stat.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi eductional & theraputic center
Full name of responsible person
Majd Pourshaikhian
Street address
Razi eductional & theraputic center, Sardare jangal Ave,
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan university of medical sciences and Health Services
Full name of responsible person
Dr Abdorrasool Sobhani
Street address
Vice-chancellor for Research, Guilan University of Medical Sciences and Health Services, Shahid Siadatai Ave., Namjoo street, Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan university of medical sciences and Health Services
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
Guilan University of Medical Sciences and Health Services
Full name of responsible person
Majid Pourshaikhian
Position
MSc of anesthesia/ Faculty member of group of anesthesia ofGuilan University of Medical Sciences and
Other areas of specialty/work
Street address
Razi eductional & theraputic center, Sardare jangal Ave,