Nebulized Dexmedetomidine Versus Neostigmine/Atropine in Postdural Puncture Headache

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Effects of Nebulized Dexmedetomidine Versus Neostigmine / Atropine in Treating Postdural Puncture Headache After Cesarean Section: A Double Blind Randomized Clinical Trial

Conditions
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Postdural Puncture Headache

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Neostigmine/atropine
* Other: Saline placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>Group D (patients will receive ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days. | Drug: Dexmedetomidine<br>* ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days.<br>* Other names: Precedex;|
| Experimental: Neostigmine/atropine<br>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. | Drug: Neostigmine/atropine<br>* nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days.<br>|
| Placebo Comparator: Saline placebo<br>Group S (patients will receive nebulization of saline placebo in 4 ml)twice daily for three days. | Other: Saline placebo<br>* nebulization of saline placebo in 4 ml) twice daily for three days.<br>* Other names: Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for Epidural blood patch | Epidural blood patch will be done in failed study drugs, traditional treatment and taking consent from patients after 72h from intervention | Day 4 | 
| Occurence of neck stiffness | If there is occurance of neck stiffness after start of PDPH | 3 days |