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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-15

Study Completion Date

2021-01-01

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.

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ondansetron

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.

Laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

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

Ondansetron 1 mg/kg, max dose 8 mg

Intervention Type DRUG

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

Palonosetron

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.

Laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

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/kg

Intervention Type DRUG

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

Interventions

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Laparoscopic sleeve gastrectomy

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

Intervention Type PROCEDURE

Palonosetron 1mcg/kg

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

Intervention Type DRUG

Ondansetron 1 mg/kg, max dose 8 mg

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

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No