Nebulized Dexmedetomidine Versus Neostigmine/Atropine in Postdural Puncture Headache

Assiut University90 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Postdural Puncture Headache

Interventions

DexmedetomidineDRUG

ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days.

Neostigmine/atropineDRUG

nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days.

Saline placeboOTHER

nebulization of saline placebo in 4 ml) twice daily for three days.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Assiut university hospital

Asyut, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 3 days

Secondary Outcomes

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

Time frame: Day 4

Occurence of neck stiffness

If there is occurance of neck stiffness after start of PDPH

Time frame: 3 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.