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NCT05202574 Clinical Trial

Comparing the Effects of Ondansetron Versus Dexamethasone on the Incidence of Post-dural Puncture Headache (PDPH) , Nausea and Vomiting After Spinal Anaesthesia of Parturients Undergoing Caesarean Section

Post-Dural Puncture Headache Clinical Trial

Official title:
Comparing the Effects of Ondansetron Versus Dexamethasone on the Incidence of Post-dural Puncture Headache (PDPH) , Nausea and Vomiting After Spinal Anaesthesia of Parturients Undergoing Caesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05202574
Other study ID # 278-7/2019
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 1, 2021
Est. completion date March 1, 2022

Study information
Verified date January 2022
Source Minia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparing dexamethasone and ondanestrone injection in ncidence of postdural puncture headache and post-partum nausea and vomiting

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date March 1, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - A total of one hundred and fifty parturients in child bearing period (20-40 years), with BMI of 23-27, and ASA physical status II, who were candidate for elective caesarean section, were enrolled in this prospective randomized study. Exclusion criteria Exclusion Criteria: 1 - Lady refusal to participate. 2. All pregnant women candidate for emergency caesarean section elligible for general anaesthesia (GA). 3.presence of any contraindications of dexamethasone (as DM and uncontrolled infection ) or any contraindication of ondansetron (as prolonged QT interval 6. Presence of cardiac, respiratory, hepatic, renal and mental diseases. 7. Coagulopathy, or any contraindication to spinal anaesthesia. 8. Presence of complicated pregnancies (such as pregnancy induced hypertension, placenta previa or eclmpsia).

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Intravenous drug
intravenous drug injection

Locations
Country Name City State
Egypt Mina Raouf ALMinya Minia

Sponsors (1)
Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of post-dural puncture hedache 24 hours post-partum
Secondary incidence of post-partum nausea and vomiting 24 hours post-partum
See also
  Status Clinical Trial Phase
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Terminated NCT02813655 - Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE) Phase 2
Completed NCT02522013 - Aminophylline for Patients With Post-Dural Puncture Headache Phase 3
Completed NCT05301387 - The Effect of Ganglion Sphenopalatine Block (GSP-block) Follow-Up
Recruiting NCT05637645 - Different Approaches of Spinal Anesthesia in Patients Undergoing Cesarean Section N/A
Recruiting NCT05116930 - Neostigmine and Glycopyrrolate for the Treatment of Headache After Dural Puncture Phase 2
Terminated NCT03430531 - Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache Phase 2
Completed NCT04401878 - SGB in Management of Patients With PDPH Using TCD N/A
Completed NCT04327726 - Effectiveness of Nebulized Dexmedetomidine for Treatment of Obstetric Post-Dural Puncture Headache N/A
Completed NCT03475784 - Two Fluid Strategies for Prevention of Post-dural Puncture Headache Phase 3
Not yet recruiting NCT06272916 - Comparison of the Effect of Aminophylline, Magnesium Sulphate and Placebo in Prevention of Post Dural Puncture Headache in Parturient Undergoing Caesarean Section.
Terminated NCT02827058 - The Influence of Needle Diameter on Post Dural Puncture Headache N/A
Not yet recruiting NCT05262933 - Effects of Preoperative Coffee Consumption in Cesarean Sections Under Spinal Anesthesia
Completed NCT04793490 - Sphenopalatine Ganglion Block for Management of Post- Dural Puncture Headache in Obstetric Patients N/A
Recruiting NCT05888324 - Factors Associated With the Onset of Chronic Headaches in Patients Who Received a Blood Patch in Post Partum
Completed NCT00370604 - Effect of Small Versus Large Epidural Needles on Postdural Puncture Headache Study N/A
Completed NCT04844229 - Bilateral Sphenopalatine Ganglion Block With or Without Bilateral Greater Occipital Nerve Block for Treatment of Obstetric Post-Dural Puncture Headache N/A
Withdrawn NCT03560349 - RCT of SPG Blocks for Post-dural Headache Phase 2
Recruiting NCT06253754 - Pathophysiological Mechanisms and Implication of Treatment in Postural Puncture Headache
Not yet recruiting NCT03385772 - The Sphenopalatine Ganglion Block for Post-dural Puncture Headache N/A