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

Comparing the Efficacy of Ondansetron, Dexamethasone, and Placebo for the Reduction of Intraoperative Nausea and Vomiting in Patients Undergoing Lower-segment Caesarean Section Under Spinal Anesthesia

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05583214

Acronym

ODP

Enrollment

Registered

2022-10-17

Start date

2022-10-31

Completion date

2023-01-31

Last updated

2022-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caesarean Section, Spinal Anesthesia

Brief summary

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.

Interventions

DRUGOndansetron 8mg

8mg of Ondansetron IV stat will be given to the group after induction of spinal anesthesia

DRUGDexamethasone 8mg

8mg of Dexamethasone IV stat will be given to the group after induction of spinal anesthesia

DRUGNormal saline

Normal saline will be given IV stat to the group after induction of spinal anesthesia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 35 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Intraoperative nausea	20 minutes after initiation of procedure	Measured by an 11-point numeric rating scale
Intraoperative vomiting	1 hour	Number of episodes of vomiting throughout the procedure

Secondary

Measure	Time frame	Description
Intraoperative pain	20 minutes after the initiation of procedure	Measured by an 11-point numeric rating scale

Countries

Pakistan

Contacts

Primary ContactMuhammad Mubariz, MBBS

mubariz1997@gmail.com+923364241055

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026