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

Spinal Anesthesia Clinical Trial

— ODP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05583214
• Other study ID #: UMO708991
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 2022
• Est. completion date: January 2023

Study information

• Verified date: October 2022
• Source: Akhtar Saeed Medical and Dental College
• Contact: Muhammad Mubariz, MBBS
• Phone: +923364241055
• Email: mubariz1997[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: January 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Caesarean Section
• Spinal Anesthesia
• Vomiting

Intervention

Drug:
• Ondansetron 8mg
8mg of Ondansetron IV stat will be given to the group after induction of spinal anesthesia
• Dexamethasone 8mg
8mg of Dexamethasone IV stat will be given to the group after induction of spinal anesthesia
• Normal saline
Normal saline will be given IV stat to the group after induction of spinal anesthesia

Locations

Country	Name	City	State
Pakistan	Akhtar Saeed Trust Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Muhammad Mubariz

Country where clinical trial is conducted

Pakistan, 

Outcome

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