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Clinical trial

Comparison of the Effect of Aminophylline, Magnesium Sulphate and Placebo in Prevention of Post Dural Puncture Headache in Parturient Undergoing Caesarean Section. A Double-blind Placebo Controlled Trial.

ID
Name
Effect drugs on headache inCS
Description
This study will be conducted to better comprehend the effect of aminophylline in comparison to magnesium sulphate on preventing and/or treating PDPH.
Trial arms
Trial start
2024-03-01
Estimated PCD
2025-04-01
Trial end
2025-06-01
Status
Not yet recruiting
Treatment
Aminophylline , magnesium sulphate and placebo
Comparison of the Effect of Aminophylline, Magnesium Sulphate and Placebo in Prevention of Post Dural Puncture Headache in Parturient Undergoing Caesarean Section
Arms:
sample size of 630 cases was calculated, divided equally into three groups.
Size
630
Primary endpoint
Effect of the study drugs on the incidence and severity of PDPH
100ml of the prepared study drug intravenously immediately after the baby was delivered and umbilical cord was clamped.
Eligibility criteria
Inclusion Criteria: * All parturient who underwent cesarean section under spinal anesthesia. * Patients who are willing to participate in the trial gave an informed consent. * ASA physical status II. * The age ranged from 20 to 40. * Body Mass Index (BMI) ranged from 25 to 30 kg/m2. Exclusion Criteria: * Patient refusal. * Allergy to the studied drugs. * Patients with contraindications to spinal anesthesia. * Those with past history of chronic headache or recent onset of acute headache were excluded. * Women who had multiple punctures (\>2) during the spinal anesthesia procedure were excluded from the study. * Patients with advanced decompensated cardiac, renal, hepatic disease.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 630, 'type': 'ESTIMATED'}}
Updated at
2024-02-22

1 organization

1 product

1 indication

Organization
Assiut University
Product
Aminophylline
Indication
Post-Dural Puncture Headache