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NCT Number: NCT04910477

Nebulized Dexmedetomidine Versus Neostigmine/Atropine in Postdural Puncture Headache

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.

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Key information

Conditions

Postdural Puncture Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases Post-Dural Puncture Headache

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Assiut university hospital

Asyut, Assuit universi, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: Precedex

Neostigmine/atropine

Drug

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

Saline Placebo

Other

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

Other names: Normal saline

Primary outcomes

  1. 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

  1. Need for Epidural blood patch

    Time frame: Day 4

    Epidural blood patch will be done in failed study drugs, traditional treatment and taking consent from patients after 72h from intervention

  2. Occurence of neck stiffness

    Time frame: 3 days

    If there is occurance of neck stiffness after start of PDPH

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 2, 2021
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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