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
• Status: Recruiting
• Phase: Phase 2
• 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
• 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).

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache
• Vomiting

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