Comparing the efficacy of intravenous Caffeine versus intravenous Aminophylline in reduction of post-spinal anesthesia headache in cesarean sections in Amiralmomenin Hospital in 2013 and 2014
Objectives: cesarean section is one of the most common surgical procedures in young women.cesarean section is performed in most cases with spinal anesthesia .one of the most important complications of spinal anesthesia is post dural puncture headache(PDPH).
The aim of this study was to determine and comparing efficacy of intravenous Aminophylline versus intravenous Caffeine in reduction of post spinal anesthesia headache in cesarean section.
Design: Randomized clinical trial, double blind, one center , phase ш clinical trial.
Setting and conduct: In this randomized clinical trial , were enrolled 210 women under elective cesarean section in Amiralmomenin Hospital in Tehran in 2013 and 2014
Participants including major eligibility criteria: Inclusion:consent to participate in the study; elective cesarean section;ASA (American Society of Anesthesiologists)=1;lack of sensivity to Caffeine and Aminophylline;No history of headache.
exclusive:The need for general anesthesia during surgery;opioide use during surgery.
Intervention: Randomly assigned patients to receive either intravenous Aminophylline 1.5 mg.Kg and intravenous caffeine 30 mg plus 100cc normal saline.
Variable: The frequency and severity of post spinal anesthesia headache were determined and compared by visual Analog Scale between two groups at the 4,24,48 hour after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030126865N1
Registration date:2016-05-14, 1395/02/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-14, 1395/02/25
Registrant information
Name
Fereshteh Odar
Name of organization / entity
Islamic Azad University Tehran Medical Science branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 6660
Email address
f.odar@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University Tehran Medical Science branch
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of intravenous Caffeine versus intravenous Aminophylline in reduction of post-spinal anesthesia headache in cesarean sections in Amiralmomenin Hospital in 2013 and 2014
Public title
Comparing the efficacy of intravenous Caffeine versus intravenous Aminophylline in reduction of post-spinal anesthesia headache in cesarean sections
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion: consent to participate in the study; elective cesarean section; ASA (American Society of Anesthesiologists)=1; lack of sensivity to Caffeine and Aminophylline; No history of headache
exclusive: The need for general anesthesia during surgery; opioide use during surgery
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
210
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Islamic Azad University Tehran Medical Science branch
Street address
KHaghani St, SHariati St, Tehran
City
Tehran
Postal code
Approval date
2015-03-01, 1393/12/10
Ethics committee reference number
IR.IAU.TMU.REC.1394.74
Health conditions studied
1
Description of health condition studied
Post-dural puncture headache
ICD-10 code
O29.4
ICD-10 code description
Spinal and epidural anaesthesia-induced headache during pregnancy
Primary outcomes
1
Description
Severity of post dural puncture headache
Timepoint
4-24-48 hour after surgery
Method of measurement
VAS (visual Analog Scale)
Secondary outcomes
1
Description
Time of headache
Timepoint
4-24-48 hour after surgery
Method of measurement
Patients According
Intervention groups
1
Description
Intervention 1:Administration of intravenous Aminophylline 1.5 mg/kg in recovery room after cesarean
Category
Prevention
2
Description
Intervention 2:Administration of intravenous caffeine 30 mg plus 100cc normal saline in recovery room after cesarean.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin
Full name of responsible person
Dr.Heydar Darvish
Street address
In front of Sardar-e Jangle park, end of Shir Mohammadi St, Naziabad
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Islamic Azad University Tehran Medical Science branch
Full name of responsible person
Dr.Hasan Eftekhar Ardebili
Street address
KHaghani St, SHariati St, Tehran
City
Tehran
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 Islamic Azad University Tehran Medical Science branch
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
Islamic Azad University Tehran Medical Science branch
Full name of responsible person
Fereshteh Odar
Position
Medical student
Other areas of specialty/work
Street address
KHaghani St, SHariati St, Tehran
City
Tehran
Postal code
Phone
+98 21 2200 6660
Fax
Email
Fereshteh.odar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Tehran Medical Science branch
Full name of responsible person
Dr.Heydar Darvish
Position
Assistant Professor of Anesthesiolog
Other areas of specialty/work
Street address
KHaghani St, SHariati St, Tehran
City
Tehran
Postal code
Phone
+98 21 2200 6660
Fax
Email
Dr-heydar-darvish@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Tehran Medical Science branch
Full name of responsible person
Fereshteh Odar
Position
Medical student
Other areas of specialty/work
Street address
KHaghani St, SHariati St, Tehran
City
Tehran
Postal code
Phone
+98 21 2200 6660
Fax
Email
Fereshteh.odar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)