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NCT Number: NCT04533867

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

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

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Key information

Conditions

Nausea, Postoperative Antiemetics Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Reported Outcomes Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting Vomiting, Postoperative

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bagcılar Training and Research Hospital, Istanbul, Turkey (Türkiye)

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic sleeve gastrectomy

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

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.

Ondansetron 1 mg/kg, max dose 8 mg

Drug

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

Primary outcomes

  1. Nause and vomiting 6hr

    Time frame: postoperative 6 hours

    Visual Analog Scale score for nausea and vomiting

  2. Nause and vomiting 24hr

    Time frame: postoperative 24 hours

    Visual Analog Scale score for nausea and vomiting

  3. Nause and vomiting 48hr

    Time frame: postoperative 48 hours

    Visual Analog Scale score for nausea and vomiting

  4. Nause and vomiting 72hr

    Time frame: postoperative 72 hours

    Visual Analog Scale score for nausea and vomiting

  5. amount of rescue anti-emetic drugs

    Time frame: postoperative seventh day

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

Secondary outcomes

  1. Pain 6hr

    Time frame: postoperative 6 hours

    Visual Analog Scale score for pain

  2. Pain 24hr

    Time frame: postoperative 24 hours

    Visual Analog Scale score for pain

  3. Pain 48hr

    Time frame: postoperative 48 hours

    Visual Analog Scale score for pain

  4. Pain 72hr

    Time frame: postoperative 72 hours

    Visual Analog Scale score for pain

Other outcomes

  1. Functional living index- Emesis

    Time frame: postoperative seventh day

    Quality of life after discharge about emesis using Functional living index- Emesis

Sponsors and collaborators

Lead sponsor

Bagcilar Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Sep 1, 2020
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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