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

NCT ID: NCT05202574

Last Updated: 2022-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-03-01

Brief Summary

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

Detailed Description

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Conditions

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Post-Dural Puncture Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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dexamethasone

Group Type ACTIVE_COMPARATOR

Intravenous drug

Intervention Type DRUG

intravenous drug injection

ondanestrone

Group Type ACTIVE_COMPARATOR

Intravenous drug

Intervention Type DRUG

intravenous drug injection

control group

Group Type PLACEBO_COMPARATOR

Intravenous drug

Intervention Type DRUG

intravenous drug injection

Interventions

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Intravenous drug

intravenous drug injection

Intervention Type DRUG

Eligibility Criteria

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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

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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Mina Maher

Lecturer of anesthesia and ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mina Raouf

ALMinya, Minya Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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mina raouf

Role: primary

01015752424

Other Identifiers

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278-7/2019

Identifier Type: -

Identifier Source: org_study_id

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