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

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

Detailed Description
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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.

Official Title
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Comparison of Palonosetron and Ondansetron for the Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery

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

Intervention / Treatment
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* Procedure: Laparoscopic sleeve gastrectomy
* Drug: Palonosetron 1mcg/kg
* Drug: Ondansetron 1 mg/kg, max dose 8 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ondansetron<br>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. | Procedure: Laparoscopic sleeve gastrectomy<br>* 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<br>Drug: Ondansetron 1 mg/kg, max dose 8 mg<br>* Injectable ondansetron 0.1 mg/kg, maximum of 8 mg was injected intravenously at the end of the bariatric surgery.<br>|
| Palonosetron<br>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. | Procedure: Laparoscopic sleeve gastrectomy<br>* 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<br>Drug: Palonosetron 1mcg/kg<br>* Injectable Palonosetron 1 mcg/kg diluted up to 5 mL with normal saline solution and injected intravenously at the end of the bariatric surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nause and vomiting 6hr | Visual Analog Scale score for nausea and vomiting | postoperative 6 hours | 
| Nause and vomiting 24hr | Visual Analog Scale score for nausea and vomiting | postoperative 24 hours | 
| Nause and vomiting 48hr | Visual Analog Scale score for nausea and vomiting | postoperative 48 hours | 
| Nause and vomiting 72hr | Visual Analog Scale score for nausea and vomiting | postoperative 72 hours | 
| amount of rescue anti-emetic drugs | Number of anti emetic metoclopramide intravenous injections during hospitalization and the postoperative one week. | postoperative seventh day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain 6hr | Visual Analog Scale score for pain | postoperative 6 hours | 
| Pain 24hr | Visual Analog Scale score for pain | postoperative 24 hours | 
| Pain 48hr | Visual Analog Scale score for pain | postoperative 48 hours | 
| Pain 72hr | Visual Analog Scale score for pain | postoperative 72 hours |