The purpose of this study was to evaluate the prophylactic effect of Dexamethasone in the prevention of headache after spinal anesthesia in patients undergoing cesarean. This study is a double blind clinical trial. 100 patients who have undergone caesarean electively or in an emergency were divided randomly into intervention and control groups. Spinal puncture was performed in all patients with Marcaine drug in a sitting position at L4-L5 through spinal needle 25 Whitaker. Patients in the intervention group took 0.15 mg dexamethasone intravenous per each kilogram of body weight immediately after cord clamping. At 24 hours and 7 days after, they were asked about the headache and compared with control group which received normal saline as placebo.
Inclusion criteria: patients aged 20 to 35; 150 to 170 cm in height; included in the ASA Class I and II and those signed a written consent.
Exclusion criteria: All patients who were not included in ASA class I and II; patients didn’t sign the written consent; to have an underlying disease; complaining about any acute or chronic headache before spinal punctures; to use any analgesic drugs in the last two days; any contraindication to spinal anesthesia; to have a history of kidney, heart and lung diseases, or drug allergy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013090314333N7
Registration date:2013-10-12, 1392/07/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-12, 1392/07/20
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study of the prophylactic effect of Dexamethasone on the headache after spinal anesthesia in patients undergoing cesarean
Public title
study of the prophylactic effect of Dexamethasone on the headache after spinal anesthesia in patients undergoing cesarean
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 20 to 35; 150 to 170 cm in height; included in the ASA Class I and II and those signed a written consent.
Exclusion criteria: All patients who were not included in ASA class I and II; patients didn’t sign the written consent; to have an underlying disease; complaining about any acute or chronic headache before spinal punctures; to use any analgesic drugs in the last two days; any contraindication to spinal anesthesia; to have a history of kidney, heart and lung diseases, or drug allergy.
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2013-01-16, 1391/10/27
Ethics committee reference number
48670/پ/7/420
Health conditions studied
1
Description of health condition studied
Headache after spinal anesthesia
ICD-10 code
O29.4
ICD-10 code description
Spinal and epidural anaesthesia-induced headache during pregnancy
Primary outcomes
1
Description
headache
Timepoint
24 hours and seven days after surgery
Method of measurement
Asking the patients(mild,medium,high)
Secondary outcomes
empty
Intervention groups
1
Description
0.15 mg Dexamethasone intravenous( per each kilogram of body weight) is prescribed to the intervention group immediately after cord clamping
Category
Treatment - Drugs
2
Description
intravenous normal saline is prescribed to the control group immediately after cord clamping
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Mohamad Nematizade
Street address
Emam Reza Hospital,Razi Boulvard,Sorkhleje
City
Kermanshah
2
Recruitment center
Name of recruitment center
Motazedi Hospital
Full name of responsible person
Dr.Mohamad Nematizade
Street address
Ferdosi Square,Motazedi Hospital
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Full name of responsible person
koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research Affairs, Kermanshah 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Parisa Golfam
Position
Anesthisiologist
Other areas of specialty/work
Street address
Emam Reza Hospital,Razi Boulvard,Sorkhleje
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
pgolfam@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)