Effect of Nebulized Dexmedetomidine on Post-dural Puncture Headache

NCT06470854 | Completed

• 1 other identifier: 36264PR665/4/24
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Post-Dural Puncture Headache

Outcome Measures

Primary Outcomes (1)

• The extent of reduction of consumed analgesia

  Efficacy of both modalities for relieve of Post Dural Puncture Headache in the women who included in the study.

  5 Months

Study Arms (2)

Group One

ACTIVE COMPARATOR

Drug: Nebulized Dexmedetomidine

Group Two

ACTIVE COMPARATOR

Procedure: Bilateral greater occipital nerve block

Interventions

Nebulized Dexmedetomidine DRUG

Nebulized 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

Group One

Bilateral greater occipital nerve block PROCEDURE

The 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.

Group Two

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women had CS under spinal anesthesia;
• Women started to complain of PDPH;

You may not qualify if:

• Women had prior history of PDPH or headache for any cause;
• Women had essential hypertension;
• Women with previous history of habitual hypotension or accidental syncope secondary to postural hypotension;
• Women with tempromandibular disorders;
• Women who refused to participate in the study were excluded.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El Gharbyia, 13511, Egypt

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: November 1, 2023
• Primary Completion: February 20, 2024
• Study Completion: March 22, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

EG (1)