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

Bagcilar Training and Research Hospital100 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Nausea, Postoperative Vomiting, Postoperative Patient Reported Outcomes Pain, Postoperative Antiemetics

Interventions

Laparoscopic sleeve gastrectomyPROCEDURE

Sleeve gastrectomy, also called a vertical sleeve gastrectomy, is a surgical weight-loss procedure. This procedure is typically performed laparoscopically, which involves inserting small instruments through multiple small incisions in the upper abdomen. During sleeve gastrectomy, about 80 percent of the stomach is removed, leaving a tube-shaped stomach about the size and shape

Palonosetron 1mcg/kgDRUG

Injectable Palonosetron 1 mcg/kg diluted up to 5 mL with normal saline solution and injected intravenously at the end of the bariatric surgery.

Ondansetron 1 mg/kg, max dose 8 mgDRUG

Injectable ondansetron 0.1 mg/kg, maximum of 8 mg was injected intravenously at the end of the bariatric surgery.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (2)

Bagcılar Training and Research Hospital

Istanbul, Turkey (Türkiye)

Surp Pırgic Armenian Hospital

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

Nause and vomiting 6hr

Visual Analog Scale score for nausea and vomiting

Time frame: postoperative 6 hours

Nause and vomiting 24hr

Visual Analog Scale score for nausea and vomiting

Time frame: postoperative 24 hours

Nause and vomiting 48hr

Visual Analog Scale score for nausea and vomiting

Time frame: postoperative 48 hours

Nause and vomiting 72hr

Visual Analog Scale score for nausea and vomiting

Time frame: postoperative 72 hours

amount of rescue anti-emetic drugs

Number of anti emetic metoclopramide intravenous injections during hospitalization and the postoperative one week.

Time frame: postoperative seventh day

Secondary Outcomes

Pain 6hr

Visual Analog Scale score for pain

Time frame: postoperative 6 hours

Pain 24hr

Visual Analog Scale score for pain

Time frame: postoperative 24 hours

Pain 48hr

Visual Analog Scale score for pain

Time frame: postoperative 48 hours

Pain 72hr

Visual Analog Scale score for pain

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.