Clinical Trials Directory

Trials / Completed

CompletedNCT06470854

Effect of Nebulized Dexmedetomidine on Post-dural Puncture Headache

Nebulized Dexmedetomidine for Post-dural Puncture Headache: A Comparative Case-Control Study Versus Bilateral Greater Occipital Nerve Block

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Tanta University · Academic / Other
Sex
Female
Age
25 Years – 45 Years
Healthy volunteers
Accepted

Summary

Dural puncture during neuroaxial procedures is the most frequent major complication that causes the development of post-dural puncture headache (PDPH) in 16%-86% of cases. PDPH could be defined as severe positional headache that usually presents during the first 72-h following accidental dural puncture. Dexmedetomidine (DXM) is a potent and highly selective α2-adrenergic agonist that was approved for ICU and procedural sedation in adults. Additionally, DXM has pleiotropic effects for its sympatholytic, amnestic, and analgesic properties. Regarding routes of administrations, DXM allows high flexibility and can be administered through intravenous (IV), intramuscular, buccal, intranasal and inhalational routes. Nebulized DXM at 1 µg/kg is a favorable alternative to the intravenous route in short duration surgeries because it attenuates heart rate response to laryngoscopy. However, the effects of nebulized DXM on blood pressure are controversial. it was assured that it has a role in reduction of the intraoperative anesthetic requirements and analgesic consumption. The prophylactic and management strategies for PDPH are heterogeneous because of the absence of clear guidelines and protocols for the management of PDPH. However, the general plan for PDPH management consists of conservative treatment and if failed invasive procedures such as blood patch were applied.

Conditions

Interventions

TypeNameDescription
DRUGNebulized DexmedetomidineNebulized Dexmedetomidine was prepared to provide 1 µg/kg and the calculated dose of DXM was diluted by 4-ml of 0.9% saline and was provided in the nebulizer to be nebulized in twice daily; i.e. every 12 hours for 72 hours
PROCEDUREBilateral greater occipital nerve blockThe injection solution was prepared by mixing 2-ml of 2% lidocaine with 2-ml (8 mg) of dexamethasone. A line was drawn extending between the mastoid process and the external occipital protuberance, this line was divided as a medial third and lateral two-thirds to localize the occipital artery and the greater occipital nerve was located on the medial side of the artery where it exits out of the trapezius fascia into the nuchal line about 5-cm lateral to midline and injection was performed bilaterally to achieve bilateral block.

Timeline

Start date
2023-11-01
Primary completion
2024-02-20
Completion
2024-03-22
First posted
2024-06-24
Last updated
2024-06-24

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06470854. Inclusion in this directory is not an endorsement.