None listed
Conditions
Brief summary
Post-operative nausea and vomiting are common and distressing after bariatric (weight-loss) surgery, and can slow recovery and prolong hospital stay. This study tests whether a single oral dose of an anti-nausea medication (netupitant with palonosetron, marketed as Akynzeo), given about one hour before anaesthesia, reduces post-operative nausea and vomiting compared with standard anti-nausea care alone. Adults undergoing elective laparoscopic bariatric surgery are randomly allocated to receive either the study medication in addition to usual care or usual care alone, in an open-label design. We measure how often and how severely patients experience nausea and vomiting in the first week after surgery, together with pain, analgesic use, the need for rescue anti-nausea medication and length of hospital stay. We expect that adding this medication will reduce post-operative nausea and vomiting and improve early recovery, which could inform routine anaesthetic care for bariatric surgery.
Interventions
Arm 1 (intervention): a single oral dose of Akynzeo (netupitant 300 mg / palonosetron 0.5 mg), one capsule, administered approximately 1 hour before induction of anaesthesia, in addition to standard anaesthetic care. Akynzeo is a fixed-combination NK1 and 5-HT3 receptor antagonist antiemetic. The intervention is a single pre-operative dose only; as the intravenous formulation is not available in Australia, the oral route is used. Administration is confirmed by the anaesthetic/clinical team. The
Arm 1 (intervention): a single oral dose of Akynzeo (netupitant 300 mg / palonosetron 0.5 mg), one capsule, administered approximately 1 hour before induction of anaesthesia, in addition to standard anaesthetic care. Akynzeo is a fixed-combination NK1 and 5-HT3 receptor antagonist antiemetic. The intervention is a single pre-operative dose only; as the intravenous formulation is not available in Australia, the oral route is used. Administration is confirmed by the anaesthetic/clinical team. The trial is open-label.
Sponsors
A/Prof Michael Talbot, St George Private Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults aged 18 years or older undergoing elective laparoscopic bariatric surgery (including sleeve gastrectomy and gastric bypass) at the study site, who are able to take oral medication before anaesthesia and are able to provide written informed consent.
Exclusion criteria
Known hypersensitivity or contraindication to netupitant, palonosetron or any component of the study medication; inability to take oral medication before surgery; pregnancy or breastfeeding; and inability to provide informed consent.
Outcome results
None listed