Comparison Between Intravenous Ondanosteron and Metclopromide Versus Ondanesteron and Dexamethasone Effects on the Prevention of Postoperative Nausea and Vomiting in Cesarean Section

NCT06810531 | Completed Phase 4

• 1 other identifier: 4959#
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to prevent intraoperative nausea and vomiting (IONV) and postoperative nausea and vomiting (PONV) through comparing the efficacy of combination ondanosteron plus metclopromide versus ondanesteron plus dexamethasonein in cesarean section . The main objective is to compare the incidence of PONV between the two groups in the first 24 hours. Patients will be randamized allocated into two groups: Group D (Ondanesterone plus dexamethasone) or Group M (ondanesterone plus metoclopramide) .

Conditions

Postoperative Nausea and Vomiting

Keywords

PONV; IONV; cesarean section; dexamethasone; metoclopramide; Ondanesterone

Outcome Measures

Primary Outcomes (1)

• incidence of PONV

  Comparing the incidence of PONV between the two groups in the first 24 hours between the two groups

  The first 24 hours postoperative

Secondary Outcomes (4)

• Incidence of IONV

  During the surgery

• Intraoperative non invasive blood pressure

  every 5 minutes for the first 20 minutes then every 10 minutes (with a maximum of 60 minutes)during the surgery

• Rescue antiemetic

  Intraoperaotive till 24 hours postoperative

• Total antiemetic dose

  The first 24 hours postoperative

Study Arms (2)

Group D (Ondanesterone plus dexamethasone)

ACTIVE COMPARATOR

patients allocated in this group will receive 4mg Ondanesterone plus 8 mg dexamethasone slowly intravenous 15 minutes before spinal anesthesia.

Drug: Ondanesterone plus dexamethasone combination

Group M (ondanesterone plus metoclopramide)

ACTIVE COMPARATOR

patients allocated in this group will receive 4mg Ondanesterone plus 10 mg metoclopramide slowly intravenous 15 minutes before spinal anesthesia.

Drug: ondanesterone plus metoclopramide combination

Interventions

Ondanesterone plus dexamethasone combination DRUG

Group D: Ondanesterone 4mg plus dexamethasone 8mg All the drugs will be prepared and diluted by normal saline in 10 ml syringe by an anesthesiologist who is not included in the study. The drugs will be slowly injected intravenous 15 minute from spinal anesthesia.

Group D (Ondanesterone plus dexamethasone)

ondanesterone plus metoclopramide combination DRUG

Group M: ondanesterone 4mg plus metoclopramide 10 mg All the drugs will be prepared and diluted by normal saline in 10 ml syringe by an anesthesiologist who is not included in the study. The drugs will be slowly injected intravenous 15 minute from spinal anesthesia.

Group M (ondanesterone plus metoclopramide)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant females scheduled for cesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA II and III pregnant patients scheduled for elective C.S under spinal anesthesia
• Age 18-45 years
• Fasting before the procedure for 8 hours from solid food intake and 2 hours from water intake

You may not qualify if:

• Patients with ASA physical status \> III.
• BMI \>40.
• History of motion sickness and extrapyramidal disease.
• Smokers.
• History of allergy to any of involved drugs in the study.
• Patients developed nausea and vomiting and/or received antiemetic drugs within 24 hours prior to surgery.
• History of hyperemesis gravidarum.
• History of peptic ulcer disease.

Sponsors & Collaborators

• Aiman Al-Touny: lead

Study Sites (1)

Suez Canal University Hospitals

Ismailia, Ismailia Governorate, 41522, 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 Officials

• Aiman Al-Touny, MD

  Suez Canal University

  PRINCIPAL INVESTIGATOR

• Abdelrahman Mahmoud, MD

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 5, 2025
• Study Start: February 5, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 9, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 18 months following article publication.
• Access Criteria: by email

Locations

EG (1)