Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache
NCT ID: NCT03997006
Last Updated: 2020-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2019-01-01
2020-01-01
Brief Summary
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Background: PDPH is the most frequent complication of procedures associated with dural puncture for spinal anesthesia or following accidental dural puncture during epidural anesthesia. Since invasive treatments have known complications, pharmacologic management may be preferable.
Patients and Methods: This was a prospective, randomized, double-blind, phase four clinical trial; carried out on 60 patients presented with PDPH at our hospital. Patients were randomly allocated into two equal groups (30 patients each); group A, received IV aminophylline, and group NA, received IV neostigmine/atropine mixture.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group A (n=30)
Aminophylline group
IV Aminophylline
IV Aminophylline (100 mg/8h)
Group NA (n=30)
Neostigmine/Atropine group
IV Neostigmine Methylsulfate + Atropine Sulphate
IV Neostigmine/Atropine mixture (20 μg/kg Neostigmine + 10 μg/kg Atropine)/8h
Interventions
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IV Aminophylline
IV Aminophylline (100 mg/8h)
IV Neostigmine Methylsulfate + Atropine Sulphate
IV Neostigmine/Atropine mixture (20 μg/kg Neostigmine + 10 μg/kg Atropine)/8h
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) physical status ≤ II
* Age from 21 to 50 years
Exclusion Criteria
* ASA physical status \> II
* Age \< 21 years or \> 50 years
* Pregnant women
* History of; chronic headache, Cluster headache, Migraine
* History of; Convulsions, Cerebrovascular accident, Previous neurological diseases
* Signs of meningismus
* Bronchial asthma
* Arrhythmia
* Hypertension
* Ischemic heart disease
* Hyperthyroidism
21 Years
50 Years
ALL
No
Sponsors
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Damanhour Teaching Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Ahmed M Shaat, MD
Role: PRINCIPAL_INVESTIGATOR
Damanhour Teaching Hospital
Locations
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Damanhour Teaching Hospital
Damanhūr, El-Beheira, Egypt
Countries
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Other Identifiers
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DTH:19001
Identifier Type: -
Identifier Source: org_study_id
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