Clinical trial NCT06254131: Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Caesarean Section
Official title: Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Caesarean Section: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ondansetron Lozenge
Postoperative Nausea and Vomiting
Caesarean Section
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of postoperative nausea and vomiting (PONV)
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Severity of postoperative nausea and vomiting (PONV)
timeFrame: 24 hours postoperatively
measure: Degree of patient satisfaction
timeFrame: 24 hours postoperatively
measure: Adverse effects
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: