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Completed

NCT Number: NCT06254131

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

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

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

Caesarean section has become increasingly popular, and it is the most performed surgical procedure. Despite consciousness allowing the patient to have an early intimate bond with the newborn, the procedure may be associated with complications. Around 30% of individuals undergoing elective procedures under general anesthetic are affected by postoperative nausea and vomiting (PONV).

PONV may decrease the quality of recovery and cause aspiration, intracranial hypertension, dehydration, acid-base disturbance, electrolyte imbalance, and neurological deterioration which leads to a prolonged hospital stay and increased medical cost.

The latest guidelines for the management of PONV recommend the administration of prophylactic antiemetic drugs (AED) as part of a multimodal therapy in high-risk adults.

Ondansetron is generally considered to be the first-line antiemetic for patients because of its favorable side effect profile. Ondansetron reduces the activity of the vagus nerve, which deactivates the vomiting center in the medulla oblongata, and also blocks serotonin receptors in the chemoreceptor trigger zone, Ondansetron is an effective drug in the prevention and treatment of PONV by having low side effects

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Ondansetron lozenge (Ondalenz ©)

Drug

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

Ondansetron iv

Drug

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

Primary outcomes

  1. Incidence of postoperative nausea and vomiting (PONV)

    Time frame: 24 hours postoperatively

    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).

Secondary outcomes

  1. Severity of postoperative nausea and vomiting (PONV)

    Time frame: 24 hours postoperatively

    Severity of postoperative nausea and vomiting will be scored at 0-4, 4-12, 12-24 hours using Nausea vomiting scores (NVS): [(0, No complaint; 1, Mild degree of nausea; 2, Moderate degree of nausea; 3, Frequent vomiting; 4, Severe vomiting (continuously)].

  2. Degree of patient satisfaction

    Time frame: 24 hours postoperatively

    Degree of patient satisfaction will be assessed on a 5-point Likert scale Patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied ; 5, extremely satisfied).

  3. Adverse effects

    Time frame: 24 hours postoperatively

    Side effects including headache, dry mouth, dizziness, visual disturbances, agitation, and sedation, will be evaluated on admission to the post anesthesia care unit (PACU) until discharge from the hospital.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Caesarean Section: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 12, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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