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

Minia University

Status and phase: Unknown; Phase 2

Conditions: Post-Dural Puncture Headache

Treatments: Drug: Intravenous drug

Study type: Interventional

Funder types: Other

Identifiers

NCT05202574

278-7/2019

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

dexamethasone

Active Comparator group

Treatment:

Drug: Intravenous drug

ondanestrone

Active Comparator group

Treatment:

Drug: Intravenous drug

control group

Placebo Comparator group

Treatment:

Drug: Intravenous drug