Palonosetron vs. Ondansetron for Postoperative Nausea and Vomiting in Bariatric Surgery

Bagcilar Training and Research Hospital

Status: Completed

Conditions: Patient Reported Outcomes; Vomiting, Postoperative; Pain, Postoperative; Nausea, Postoperative; Antiemetics

Treatments: Drug: Palonosetron 1mcg/kg; Procedure: Laparoscopic sleeve gastrectomy; Drug: Ondansetron 1 mg/kg, max dose 8 mg

Study type: Observational

Funder types: Other

Identifiers

NCT04533867

Beren Hacım 3

Details and patient eligibility

About

Evaluate the safety and efficacy of palonosetron versus ondansetron to reduce and control post-operative nausea in bariatric surgery.

Full description

Postoperative nausea and vomiting (PONV) is an undesirable clinical condition that increases the likelihood of dehiscence, bleeding, pulmonary aspiration of gastric contents, and electrolyte loss that lead to increased costs, prolonged hospital stays, and delayed recovery. In recent years, selective serotonin 5-hydroxytryptamine sub-type 3 (5-HT3) receptor antagonists such as ondansetron, granisetron, palonosetron have been introduced because they are effective in the prevention and treatment of PONV in bariatric surgery. In this study, the effects of ondansetron and palonosetron on PONV in patients who undergo sleeve gastrectomy will be compared.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All morbidity obese patients underwent laparoscopic sleeve gastrectomy

Exclusion criteria

drug allergy, intractable nausea and vomiting, gastroesophageal reflux disease, pregnancy, menstruation, the occurrence of nausea or vomiting episodes in the last 24 h prior to surgery, the use of corticosteroids, smoking, alcoholism, the use of psychoactive drugs or any other drug with antiemetic effects, hypersensitivity to other 5-HT3 antagonists, emergency surgeries and chemotherapy within.

Trial design

100 participants in 2 patient groups

Ondansetron

Description:

In Group B (n = 50): Intravenous injection of ondansetron 0.1 mg/kg diluted up to 5 mL with normal saline solution in a maximum dose of 8 mg is performed at the end of bariatric surgery while patients are in anesthesia. The drug is injected once.

Treatment:

Procedure: Laparoscopic sleeve gastrectomy

Drug: Ondansetron 1 mg/kg, max dose 8 mg

Palonosetron

Description:

The antiemetics used are palonosetron in Group A (n = 50): Intravenous injection of Palonosetron 1 mcg/kg diluted up to 5 mL with normal saline solution is performed at the end of bariatric surgery while patients are in anesthesia. The drug is injected once.

Treatment:

Procedure: Laparoscopic sleeve gastrectomy

Drug: Palonosetron 1mcg/kg