Nebulized Dexmedetomidine Versus Neostigmine/Atropine in Postdural Puncture Headache
Comparative Effects of Nebulized Dexmedetomidine Versus Neostigmine / Atropine in Treating Postdural Puncture Headache After Cesarean Section: A Double Blind Randomized Clinical Trial
1 other identifier
interventional
90
1 country
1
Brief Summary
In our study, we will compare a new route of nebulization for effectiveness between dexmedetomidine, neostigmine/atropine and saline placebo for females complained of postdural puncture headache (PDPH) after cesarean section.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2021
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2021
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedFirst Posted
Study publicly available on registry
June 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2021
CompletedSeptember 8, 2021
September 1, 2021
3 months
May 25, 2021
September 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
visual analog scale score (VAS) ≤3 within 72 hour.
change in visual analog scale score (VAS )for the assessment of the degree of headache (with 0 representing no headache and 10 cm representing the worst imaginable headache). a visual analog scale score ≤3 within 72 hour after intervention will be recorded.
3 days
Secondary Outcomes (2)
Need for Epidural blood patch
Day 4
Occurence of neck stiffness
3 days
Study Arms (3)
Dexmedetomidine
EXPERIMENTALGroup D (patients will receive ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days.
Neostigmine/atropine
EXPERIMENTALGroup N (patients will receive nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days.
Saline placebo
PLACEBO COMPARATORGroup S (patients will receive nebulization of saline placebo in 4 ml)twice daily for three days.
Interventions
ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days.
nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days.
nebulization of saline placebo in 4 ml) twice daily for three days.
Eligibility Criteria
You may qualify if:
- \- Clinical diagnosis of postdural puncture headache (PDPH) after elective cesarean section under spinal anesthesia.
You may not qualify if:
- Hypersensitivity of dexmedetomidine, neostigmine or atropine
- Overactive thyroid gland
- Myasthenia gravis
- Closed angle glaucoma
- High blood pressure and coronary artery disease.
- withdrawal of consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut university hospital
Asyut, Assuit universi, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Omar Soliman
Omar makram
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of anesthesia and ICU
Study Record Dates
First Submitted
May 25, 2021
First Posted
June 2, 2021
Study Start
June 1, 2021
Primary Completion
September 1, 2021
Study Completion
September 3, 2021
Last Updated
September 8, 2021
Record last verified: 2021-09