Comparative Effects of Nebulized Dexmedetomidine Versus Neostigmine / Atropine in Treating Postdural Puncture Headache After Cesarean Section: A Double Blind Randomized Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- Dexmedetomidine
- Conditions
- Postdural Puncture Headache
- Sponsor
- Assiut University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- visual analog scale score (VAS) ≤3 within 72 hour.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Detailed Description
A written informed consent will be taken from the patients. The study will involve female adults (age 18-40years) of American society of anesthesiologists (ASA) I-II who are listed for elective cesarean section under spinal anesthesia and suffer from postoperative postdural puncture headache (PDPH). Patients will be assigned randomly to three groups (30 subjects each) after PDPH diagnosis was established. First 90 patients developed PDPH will be assessed for study eligibility. Group D (patients will receive ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days. Group N (patients will receive nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days. Group S (patients will receive nebulization of saline placebo in 4 ml) twice daily for three days.
Investigators
Omar Makram Soliman
Lecturer of anesthesia and ICU
Assiut University
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of postdural puncture headache (PDPH) after elective cesarean section under spinal anesthesia.
Exclusion Criteria
- •Hypersensitivity of dexmedetomidine, neostigmine or atropine
- •Overactive thyroid gland
- •Myasthenia gravis
- •Closed angle glaucoma
- •High blood pressure and coronary artery disease.
- •withdrawal of consent
Arms & Interventions
Dexmedetomidine
Group D (patients will receive ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days.
Intervention: Dexmedetomidine
Neostigmine/atropine
Group N (patients will receive nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days.
Intervention: Neostigmine/atropine
Saline placebo
Group S (patients will receive nebulization of saline placebo in 4 ml)twice daily for three days.
Intervention: Saline placebo
Outcomes
Primary Outcomes
visual analog scale score (VAS) ≤3 within 72 hour.
Time Frame: 3 days
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.
Secondary Outcomes
- Need for Epidural blood patch(Day 4)
- Occurence of neck stiffness(3 days)