Effect of Palonosetron, Ondansetron and Dexamethasone in the Prevention of Postoperative Nausea and Vomiting

• Status: Enrolling by invitation
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: All

Summary

Postoperative nausea and vomiting (PONV) is an important outcome for the patient; patients generally rate PONV as worse than postoperative pain. The term PONV is typically used to describe nausea and/or vomiting or retching in the post-anesthetic care unit or within 24 hours postoperatively. Postoperative nausea and vomiting usually resolves or is treated without sequelae, but may require unexpected hospitalization and delay recovery room discharge. In the prophylaxis of PONV, ondansetron is one of the first widely used 5-HT3 receptor antagonists. Palonosetron, on the other hand, is a second generation 5-HT3 receptor antagonist with a half-life of 40 hours and higher receptor binding affinity. In addition, dexamethasone is another class of drugs that has emerged as a potentially useful prophylaxis for patients who are a corticosteroid and are at high risk of PONV with minimal side effects. However, a multimodal approach rather than antiemetic prophylaxis with a single pharmacological agent is described as a good way to reduce PONV, especially in high-risk cases. Conducted a previous systematic review and meta-analysis of the addition of dexamethasone to various 5-HT3 antagonists; however, it included only one study of palonosetron + dexamethasone. Since then, several meta-analyses have been performed on the efficacy of the combination of palonosetron and dexamethasone. This study was designed to find out the incidence of PONV by comparing the efficacy of the combination of palonosetron-dexamethasone, ondansetron-dexamethasone and dexamethasone alone for the prevention of PONV in patients undergoing pediatric laparoscopic surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Selcuk University
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Ondansetron; Palonosetron

Criteria

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) Class I-II,

• Between the ages of 7-18,

• Patients with written informed consent from themselves and their parents

Exclusion Criteria:

• Allergic to study drugs,

• Taking antiemetic drugs 24 hours before the operation,

• Gastroesophageal reflux disease,

• Body mass index (BMI) >35 kg/m 2,

• In the period of menstruation,

• Receiving cancer chemotherapy in the last four weeks,

• Allergy to NSAIDs,

• Patients with bronchial asthma