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

Tanta University

Status: Completed

Conditions: Caesarean Section; Ondansetron Lozenge; Postoperative Nausea and Vomiting

Treatments: Drug: Ondansetron lozenge (Ondalenz ©); Drug: Ondansetron IV

Study type: Interventional

Funder types: Other

Identifiers

NCT06254131

36264PR460/12/2023

Details and patient eligibility

About

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

Full description

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

Enrollment: 75 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Ondansetron lozenge (Ondalenz ©)

Experimental group

Description:

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

Treatment:

Drug: Ondansetron lozenge (Ondalenz ©)

Ondansetron IV

Experimental group

Description:

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

Treatment:

Drug: Ondansetron IV

Control group

No Intervention group

Description:

Patients will not receive ondansetron as a control group.