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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-10

Study Completion Date

2024-10-05

Brief Summary

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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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Detailed Description

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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

Conditions

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Ondansetron Lozenge Postoperative Nausea and Vomiting Caesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Ondansetron lozenge (Ondalenz ©)

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

Group Type EXPERIMENTAL

Ondansetron lozenge (Ondalenz ©)

Intervention Type DRUG

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

Ondansetron IV

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

Group Type EXPERIMENTAL

Ondansetron IV

Intervention Type DRUG

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

Control group

Patients will not receive ondansetron as a control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ondansetron lozenge (Ondalenz ©)

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

Intervention Type DRUG

Ondansetron IV

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No