RecruitingPhase 4ACTRN12620000455965

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


Sponsor

St Vincent's Hospital Melbourne

Enrollment

160 participants

Start Date

Feb 3, 2021

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

Nausea and vomiting after surgery is one of the most common and unpleasant complications of bariatric (weight loss) operations, occurring particularly frequently after laparoscopic (keyhole) procedures. Feeling very sick after surgery can slow recovery, make it harder to stay hydrated, and reduce overall satisfaction. This trial tests whether a combination medication called Akynzeo (which contains two anti-nausea drugs: netupitant and palonosetron) can better prevent post-operative nausea and vomiting in people having bariatric surgery compared to standard anti-nausea treatments. Participants are randomly assigned to receive either Akynzeo or the standard anti-nausea regimen before their operation. Nausea, vomiting, and the need for rescue anti-nausea medications are tracked in the hours and days following surgery. You may be eligible if you are between 18 and 70 years old and scheduled for elective laparoscopic bariatric surgery. A known allergy to any of the study anti-nausea medications, significant psychiatric illness, kidney impairment, or use of medications that interact with the study drugs would make you ineligible.

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

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)

St Vincent's Private Hospital - Fitzroy

VIC, Australia

Epworth Freemasons (Clarendon Street) - East Melbourne

VIC, Australia

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ACTRN12620000455965