Akynzeo for post-operative nausea and vomiting after bariatric surgery.
A randomised controlled trial of Akynzeo® (Netupitant/Palonosetron) versus standard treatment for the prevention of postoperative nausea and vomiting after bariatric surgery
St Vincent's Hospital Melbourne
160 participants
Feb 3, 2021
Interventional
Conditions
Summary
Postoperative nausea and vomiting (PONV) is common in the setting of bariatric surgery and can be detrimental to patient recovery. Multimodal antiemetic strategies have been shown to be more effective than monotherapy to target the high incidence of PONV after laparoscopic surgery. The proposed randomised controlled trial will evaluate the efficacy of Akynzeo® (netupitant/palonosetron) to prevent PONV in patients with morbid obesity following bariatric surgery.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
A sleeve gastrectomy involves removal of a portion of stomach while Roux-en-y gastric bypass is reconstruction of the anatomical configuration of the stomach and proximal small bowel without removing stomach. Both cohorts will be randomised to intervention or control. The interventional drug 300mg Netupitant & 0.5mg Palonosetron hydrochloride will be administered orally by an anaesthetic nurse 1-2 hours before bariatric surgery. The anaesthetic nurse will record that the drug was administered and the time patient took the drug on a study case report form. Just before surgery, the anaesthetist will check through the case report form that the interventional drug has been administered and initial beside it. Postoperatively, patients in the treatment arm will receive regular antiemetic with cyclizine 25mg orally in tablet form three times a day for 24 hours while those in the standard treatment arm will receive this in addition to ondansetron 8mg orally in tablet form three times a day for 24 hours. Adherence to treatment will be extracted from the medical chart.
Locations(2)
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ACTRN12620000455965