Effectiveness of Nebulized Dexmedetomidine for Treatment of Obstetric Post-Dural Puncture Headache

NCT04327726 | Completed

• 1 other identifier: 6075-26-4-2020
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Postdural puncture headache (PDPH) is a common complication, following neuraxial techniques. The obstetric population is particularly prone to PDPH. Therefore, treatment of PDPH is a key issue in obstetric anesthesia. Dexmedetomidine is a highly selective, centrally acting α2-adrenergic agonist with analgesic and anxiolytic effects. Moreover, it decreases cerebral blood flow (CBF) in humans and animals secondary to cerebrovascular vasoconstriction. It has been used via the intranasal and inhalational routes for many purposes including premedication, sedation and postoperative analgesia. Because of its desirable properties, we hypothesized that dexmedetomidine nebulization could be effective in the treatment of patients suffering from PDPH after caesarean section.

Conditions

Post-Dural Puncture Headache

Outcome Measures

Primary Outcomes (2)

• visual analogue score (VAS)

  using the 10-cm visual analogue score (VAS) where score 0 is no headache and 10 is the worst imaginable headache with 1-3 classified as mild, 4-6 moderate, and 7-10 severe our aim to get VAS \</= 3 at 24 hour from starting treatment

  24 hour

• Lybecker headache classification score

  our aim to get Lybecker score \< 2 at 24hour following treatment Lybecker et al. classification of PDPH score 1: Mild PDPH where daily activities slightly restricted. Patient is not bedridden. No associated symptoms\*. Score 2:Moderate: Daily activities significantly restricted and most of the day patient is bedridden with or without associated symptoms. Score 3:Severe Daily activities completely restricted, patient is bedridden all the day and always with associated symptoms Associated symptoms include: Nausea, vomiting, vertigo, dizziness, tinnitus Photophobia, diplopia, and neck stiffness.

  24 hour

Secondary Outcomes (2)

• the effects of nebulized dexmedetomidine on cerebral blood flow by using Trans-Cranial Doppler (TCD)

  72 hours

• adverse effects related to nebulized Dexmedetomidine

  72 hours

Study Arms (2)

Control group

PLACEBO COMPARATOR

received ultrasonic nebulization of 4mL 0.9% saline twice daily for 3 days

Other: 0.9% Saline Nebulization

Dexmedetomidine group

ACTIVE COMPARATOR

received ultrasonic nebulization of 1 µg/kg dexmedetomidine diluted in 4mL 0.9% saline twice daily for 3 days. The intervention will be continued until achieving a VAS score ≤3 and Lybecker et al. classification score \<2 and or for a maximum of 72 hours. Patients in this group who achieved the target scores before 72 hours will be given 4ml of saline 0.9% nebulization to maintain blinding.

Drug: Dexmedetomidine Nebulization

Interventions

Dexmedetomidine Nebulization DRUG

ultrasonic nebulization of 1 µg/kg dexmedetomidine for PDPH treatment

Dexmedetomidine group

0.9% Saline Nebulization OTHER

nebulization of 4mL 0.9% saline

Control group

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Post-partum females diagnosed with PDPH after elective caesarean section under spinal anesthesia and with visual analogue score (VAS) ≥ 4 and Lybecker et al. classification score ≥2.
• Age 21- 40 years old.
• ASA I and ASA II.
• Accepted mental state of the patient.

You may not qualify if:

• Patient refusal.
• ASA Grade III and IV.
• Emergent caesarean section.
• Inadequate temporal window.
• Hypertensive disorders of the pregnancy.
• Atrial fibrillation.
• History of allergy to local anesthetics.
• History of chronic headache, migraine, convulsions, and cerebrovascular accident.
• Contraindication to spinal anesthesia: coagulopathy, infection at site of injection

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Sharqia Province, 44519, Egypt

Location

Related Publications (17)

• Sachs A, Smiley R. Post-dural puncture headache: the worst common complication in obstetric anesthesia. Semin Perinatol. 2014 Oct;38(6):386-94. doi: 10.1053/j.semperi.2014.07.007. Epub 2014 Aug 19.

  PMID: 25146108 BACKGROUND

• Bardon J, LE Ray C, Samama CM, Bonnet MP. Risk factors of post-dural puncture headache receiving a blood patch in obstetric patients. Minerva Anestesiol. 2016 Jun;82(6):641-8. Epub 2015 Jul 29.

  PMID: 26222393 BACKGROUND

• FitzGerald S, Salman M. Postdural puncture headache in obstetric patients. Br J Gen Pract. 2019 Apr;69(681):207-208. doi: 10.3399/bjgp19X702125. No abstract available.

  PMID: 30923161 BACKGROUND

• Shah A, Bhatia PK, Tulsiani KL. Post dural puncture headache in caesarean section-a comparative study using 25G Quincke, 27G Quincke and 27G Whitacre needle. Indian J Anaesth 2002; 46(5):373-377.

  BACKGROUND

• Turnbull DK, Shepherd DB. Post-dural puncture headache: pathogenesis, prevention and treatment. Br J Anaesth. 2003 Nov;91(5):718-29. doi: 10.1093/bja/aeg231.

  PMID: 14570796 BACKGROUND

• Amorim JA, Gomes de Barros MV, Valenca MM. Post-dural (post-lumbar) puncture headache: risk factors and clinical features. Cephalalgia. 2012 Sep;32(12):916-23. doi: 10.1177/0333102412453951. Epub 2012 Jul 27.

  PMID: 22843225 BACKGROUND

• Uyar Turkyilmaz E, Eryilmaz NC, Guzey NA, Moraloglu O. [Bilateral greater occipital nerve block for treatment of post-dural puncture headache after caesarean operations]. Rev Bras Anestesiol. 2016 Sep-Oct;66(5):445-50. doi: 10.1016/j.bjan.2015.12.001. Epub 2016 Jul 18. Portuguese.

  PMID: 27445257 BACKGROUND

• Tsaousi GG, Bilotta F. Is dexmedetomidine a favorable agent for cerebral hemodynamics? Indian J Crit Care Med. 2016 Jan;20(1):1-2. doi: 10.4103/0972-5229.173675. No abstract available.

  PMID: 26955209 BACKGROUND

• Tang C, Huang X, Kang F, Chai X, Wang S, Yin G, Wang H, Li J. Intranasal Dexmedetomidine on Stress Hormones, Inflammatory Markers, and Postoperative Analgesia after Functional Endoscopic Sinus Surgery. Mediators Inflamm. 2015;2015:939431. doi: 10.1155/2015/939431. Epub 2015 Jun 25.

  PMID: 26199465 BACKGROUND

• Jaakola ML, Salonen M, Lehtinen R, Scheinin H. The analgesic action of dexmedetomidine--a novel alpha 2-adrenoceptor agonist--in healthy volunteers. Pain. 1991 Sep;46(3):281-285. doi: 10.1016/0304-3959(91)90111-A.

  PMID: 1684653 BACKGROUND

• Gertler R, Brown HC, Mitchell DH, Silvius EN. Dexmedetomidine: a novel sedative-analgesic agent. Proc (Bayl Univ Med Cent). 2001 Jan;14(1):13-21. doi: 10.1080/08998280.2001.11927725.

  PMID: 16369581 BACKGROUND

• Gerlach AT, Dasta JF. Dexmedetomidine: an updated review. Ann Pharmacother. 2007 Feb;41(2):245-52. doi: 10.1345/aph.1H314. Epub 2007 Feb 13. Erratum In: Ann Pharmacother. 2007 Mar;41(3):530-1.

  PMID: 17299013 BACKGROUND

• Drummond JC, Dao AV, Roth DM, Cheng CR, Atwater BI, Minokadeh A, Pasco LC, Patel PM. Effect of dexmedetomidine on cerebral blood flow velocity, cerebral metabolic rate, and carbon dioxide response in normal humans. Anesthesiology. 2008 Feb;108(2):225-32. doi: 10.1097/01.anes.0000299576.00302.4c.

  PMID: 18212567 BACKGROUND

• Kumar A, Kumar A, Sinha C, Anant M, Singh JK. Dexmedetomidine nebulization: an answer to post-dural puncture headache? Int J Obstet Anesth. 2019 Nov;40:155-156. doi: 10.1016/j.ijoa.2019.06.004. Epub 2019 Jun 19. No abstract available.

  PMID: 31345663 BACKGROUND

• Lybecker H, Djernes M, Schmidt JF. Postdural puncture headache (PDPH): onset, duration, severity, and associated symptoms. An analysis of 75 consecutive patients with PDPH. Acta Anaesthesiol Scand. 1995 Jul;39(5):605-12. doi: 10.1111/j.1399-6576.1995.tb04135.x.

  PMID: 7572008 BACKGROUND

• Bathala L, Mehndiratta MM, Sharma VK. Transcranial doppler: Technique and common findings (Part 1). Ann Indian Acad Neurol. 2013 Apr;16(2):174-9. doi: 10.4103/0972-2327.112460.

  PMID: 23956559 BACKGROUND

• Mowafy SMS, Ellatif SEA. Effectiveness of nebulized dexmedetomidine for treatment of post-dural puncture headache in parturients undergoing elective cesarean section under spinal anesthesia: a randomized controlled study. J Anesth. 2021 Aug;35(4):515-524. doi: 10.1007/s00540-021-02944-6. Epub 2021 May 16.

  PMID: 33993346 DERIVED

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 Officials

• Sherif M Mowafy, MD

  Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University

  PRINCIPAL INVESTIGATOR

• Shereen E Abd Ellatif, MD

  Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will not be aware of their group assignment, and the medications will be prepared by an anesthetist who is not involved in the study. The anesthetist who will assess the participants after the intervention is blinded to the group allocation and single experienced operator who is unaware of patient group and study purpose will perform all Trans-Cranial Doppler (TCD) measurements.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and surgical intensive care

Study Record Dates

• First Submitted: March 28, 2020
• First Posted: March 31, 2020
• Study Start: May 1, 2020
• Primary Completion: January 30, 2021
• Study Completion: February 28, 2021
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: the individual participant data and any additional supporting information will become available starting 6 months after publication.
• Access Criteria: by contacting the study director

Locations

EG (1)