- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02150304
Aminophylline Prophylaxis For Postdural Puncture Headache
August 4, 2015 updated by: İBRAHİM ÖZTÜRK, Diskapi Yildirim Beyazit Education and Research Hospital
Phase IV Study of Intravenous Aminophylline During Spinal Anesthesia
postdural puncture headache is a rare but serious complication of spinal anesthesia.
many drugs were studied in prevention or treatment of that complication.
However, there are limited numbers of trials about intravenous aminophylline for prevention.
because of that we retrospectively aimed to investigate the effectiveness of aminophylline for postdural puncture headache in cesarean section.
Study Overview
Status
Completed
Conditions
Detailed Description
retrospective trial about the effect of intravenous aminophylline for prevention of PDPH after caserean section with spinal anesthesia
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey, 06110
- Dışkapı Yıldırım Beyazıt Education and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
patient records form who experinced headache after caserean section with spinal anesthesia were retrospectively evaluated
Description
Inclusion Criteria:
- patients aolder than 18 years old
Exclusion Criteria:
- conversion to general anesthesia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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intravenous aminophylline
intravenous aminophylline use during spinal anesthesia
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no intravenous aminophylline
no use of intravenous aminophylline during spinal anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
postdural puncture headache
Time Frame: postoperative 2 weeks
|
postoperative 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: ibrahim öztürk, M.D., Dışkapı Yıldırım Beyazıt Education and Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Naghibi K, Hamidi M. Prophylactic administration of aminophylline plus dexamethasone reduces post-dural puncture headache better than using either drug alone in patients undergoing lower extremity surgery. Adv Biomed Res. 2014 Jan 9;3:5. doi: 10.4103/2277-9175.124631. eCollection 2014.
- Basurto Ona X, Uriona Tuma SM, Martinez Garcia L, Sola I, Bonfill Cosp X. Drug therapy for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD001792. doi: 10.1002/14651858.CD001792.pub3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
May 24, 2014
First Submitted That Met QC Criteria
May 26, 2014
First Posted (Estimate)
May 29, 2014
Study Record Updates
Last Update Posted (Estimate)
August 5, 2015
Last Update Submitted That Met QC Criteria
August 4, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PDPHAMINOPHYLLINE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postdural Puncture Headache
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Ain Shams UniversityCompleted
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