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Nebulized Dexmedetomidine vs Neostigmine/Atropine for PDPH
NCT04910477Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2021
- Primary completion
- Sep 2021
- Countries
- 1
- Sponsor
- Assiut University
- Modality
- Classical Binding Small Molecules
- Conditions
- post-dural puncture headache (PDPH)
01
Overview
Phase 3, randomised, double-blind trial in post-dural puncture headache (PDPH) comparing Dexmedetomidine, Neostigmine/Atropine and Placebo (3 arms). Primary endpoint: Visual Analog Scale Score at 3 days. Started Jun 2021; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Dexmedetomidine
Nebulized Dexmedetomidine (1 mg/kg) twice daily
Neostigmine/Atropine
Nebulized Neostigmine (20 µg/kg) + Atropine (10 µg/kg) twice daily
Placebo
Nebulized Saline Placebo twice daily
03
Who it enrols
Adult females (18-40 years) with ASA I-II status who develop postdural puncture headache after elective cesarean section under spinal anesthesia.
04
Endpoints
Primary
Visual Analog Scale Score
Secondary
Need for Epidural Blood Patch
Occurrence of Neck Stiffness
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