Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Caesarean Section

NCT06254131 | Completed

• 1 other identifier: 36264PR460/12/2023
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to estimate the effect of preoperative ondansetron lozenge on prevention of postoperative nausea and vomiting in caesarean section.

Conditions

Ondansetron Lozenge; Postoperative Nausea and Vomiting; Caesarean Section

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative nausea and vomiting (PONV)

  The incidence of nausea and vomiting will be evaluated through the Bellville scoring scale (lack of nausea and vomiting=0, nausea=1, nausea with belching=2, and vomiting=3).

  24 hours postoperatively

Secondary Outcomes (3)

• Severity of postoperative nausea and vomiting (PONV)

  24 hours postoperatively

• Degree of patient satisfaction

  24 hours postoperatively

• Adverse effects

  24 hours postoperatively

Study Arms (3)

Ondansetron lozenge (Ondalenz ©)

EXPERIMENTAL

Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.

Drug: Ondansetron lozenge (Ondalenz ©)

Ondansetron IV

EXPERIMENTAL

Patients will receive 4 mg of ondansetron IV approximately 30 minutes before the end of surgery.

Drug: Ondansetron IV

Control group

NO INTERVENTION

Patients will not receive ondansetron as a control group.

Interventions

Ondansetron lozenge (Ondalenz ©) DRUG

Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.

Ondansetron lozenge (Ondalenz ©)

Ondansetron IV DRUG

Patients will receive 4 mg of ondansetron IV approximately 30 minutes before the end of surgery.

Ondansetron IV

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Women caesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age from 18 to 35 years old.
• American Society of Anesthesiologists (ASA) physical status II.
• Undergoing caesarean section under general anesthesia.

You may not qualify if:

• Medical history of alcohol or drug abuse.
• History of allergic reactions or intolerance to any study medications.
• BMI \> 40 kg/m2.
• History of nausea and/or vomiting within 24 h prior procedures.
• History of treatment with antiemetic medication for nausea or vomiting within 24 h of their procedure.
• History of chemotherapy treatment within 4 weeks prior to surgery.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: January 27, 2024
• First Posted: February 12, 2024
• Study Start: February 10, 2024
• Primary Completion: October 5, 2024
• Study Completion: October 5, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)