Nebulized Dexmedetomidine Versus Neostigmine/Atropine in Postdural Puncture Headache

Phase 3

Completed

• Conditions: Postdural Puncture Headache
• Interventions: Drug: Neostigmine/atropine; Other: Saline placebo; Drug: Dexmedetomidine

• Registration Number: NCT04910477
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-27
• Study Start: 2021-06-01
• Study First Posted: 2021-06-02
• Status Verified: 2021-09
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-03
• Last Update Submitted: 2021-09-05
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neostigmine/atropine	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.
Saline placebo	Saline placebo	Group S (patients will receive nebulization of saline placebo in 4 ml)twice daily for three days.
Dexmedetomidine	Dexmedetomidine	Group D (patients will receive ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days.

Primary Outcome Measures

Name	Time	Method
visual analog scale score (VAS) ≤3 within 72 hour.	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 Outcome Measures

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

Trial Locations

Locations (1)

Assiut university hospital; 🇪🇬 Assiut, Egypt