Nebulized Dexmedetomidine Versus Neostigmine/Atropine in Postdural Puncture Headache

Assiut University

Status and phase: Completed; Phase 3

Conditions: Postdural Puncture Headache

Treatments: Other: Saline placebo; Drug: Dexmedetomidine; Drug: Neostigmine/atropine

Study type: Interventional

Funder types: Other

Identifiers

NCT04910477

17300608

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Dexmedetomidine

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine

Neostigmine/atropine

Experimental group

Description:

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.

Treatment:

Drug: Neostigmine/atropine

Saline placebo

Placebo Comparator group

Description:

Group S (patients will receive nebulization of saline placebo in 4 ml)twice daily for three days.

Treatment:

Other: Saline placebo