Nebulized Dexmedetomidine Versus Neostigmine/Atropine in Postdural Puncture Headache

Postdural Puncture Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04910477
• Other study ID #: 17300608
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2021
• Est. completion date: September 3, 2021

Study information

• Verified date: September 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 3, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache
• Postdural Puncture Headache

Intervention

Drug:
• Dexmedetomidine
ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days.
• Neostigmine/atropine
nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days.

Other:
• Saline placebo
nebulization of saline placebo in 4 ml) twice daily for three days.

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Occurence of neck stiffness	If there is occurance of neck stiffness after start of PDPH	3 days