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Effect of Nebulized Dexmedetomidine on Post-dural Puncture Headache

T

Tanta University

Status

Completed

Conditions

Post-Dural Puncture Headache

Treatments

Procedure: Bilateral greater occipital nerve block
Drug: Nebulized Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT06470854
36264PR665/4/24

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

Female

Ages

25 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Women had CS under spinal anesthesia;
  • Women started to complain of PDPH;
  • Women were free of exclusion criteria.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Group One
Active Comparator group
Treatment:
Drug: Nebulized Dexmedetomidine
Group Two
Active Comparator group
Treatment:
Procedure: Bilateral greater occipital nerve block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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