None listed
Conditions
Brief 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.
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 a
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.
Sponsors
St Vincent's Hospital Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Patients eligible for participation in this trial include all adults aged 18 years and above and below the age of 70 years undergoing elective laparoscopic bariatric surgery.
Exclusion criteria
Patients will be excluded if they have a known allergy to any antiemetic to be administered as part of the trial (netupitant, palonosetron or standard treatment), significant psychiatric disease, renal impairment or those taking any medications with known interaction with the study drugs (amiodarone, carbamazepine, colchicine, etc.).
Outcome results
None listed