Evaluating the Effectiveness of Ondansetron Versus Dexamethasone Versus Placebo for the Control of Intraoperative Nausea and Vomiting in Patients Undergoing Lower-segment Caesarean Section Under Spinal Anesthesia (ODP)

Muhammad Mubariz

Status and phase: Not yet enrolling; Phase 4

Conditions: Caesarean Section; Spinal Anesthesia

Treatments: Drug: Normal saline; Drug: Ondansetron 8mg; Drug: Dexamethasone 8mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05583214

UMO708991

Details and patient eligibility

About

The goal of this randomized controlled trial is to evaluate the effectiveness of Ondansetron, Dexamethasone, and Placebo for intraoperative nausea and vomiting in patients undergoing caesarian section under spinal anesthesia. The main question it aims to answer are:

Which drug is the best at reducing the incidence of intraoperative nausea and vomiting.

Which drug is the best at reducing intraoperative pain.

Participants will be randomly divided into three groups, each will be given a different drug labelled A, B, or C.

A rating scale will be used to evaluate the severity of intraoperative nausea and pain. Episodes of vomiting will be recorded.

Data collected from the three groups will be analyzed using SPSS software.

Enrollment: 90 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age above 20 but less than 35 years old
• Given informed consent
• No contraindication to spinal anesthesia
• ASA I or II

Exclusion criteria

• Age less than 20 or more than 35 years old
• Non-consenting
• Contraindication to spinal anesthesia
• ASA III or IV

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

Ondansetron

Experimental group

Description:

Patients given Ondansetron (8mg)

Treatment:

Drug: Ondansetron 8mg

Dexamethasone

Experimental group

Description:

Patients given Dexamethasone (8mg)

Treatment:

Drug: Dexamethasone 8mg

Placebo

Placebo Comparator group

Treatment:

Drug: Normal saline