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Trial registered on ANZCTR


Registration number
ACTRN12620000455965
Ethics application status
Approved
Date submitted
25/02/2020
Date registered
8/04/2020
Date last updated
23/03/2023
Date data sharing statement initially provided
8/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Akynzeo for post-operative nausea and vomiting after bariatric surgery.
Scientific title
A randomised controlled trial of Akynzeo® (Netupitant/Palonosetron) versus standard treatment for the prevention of postoperative nausea and vomiting after bariatric surgery
Secondary ID [1] 300422 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
morbid obesity 316080 0
Post-operative nausea and vomitting 316515 0
Condition category
Condition code
Anaesthesiology 314357 314357 0 0
Anaesthetics
Diet and Nutrition 314358 314358 0 0
Obesity
Surgery 314757 314757 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 316721 0
Treatment: Drugs
Comparator / control treatment
Standard of care: Patients in the standard treatment arm will also receive ondansetron 8mg orally in tablet form. Postoperatively, patients in the standard of care arm will receive regular antiemetic with cyclizine 25mg and ondansetron 8mg in tablet orally in tablet form three times a day for 24 hours. Adherence to treatment will be extracted from the medical chart.
Control group
Active

Outcomes
Primary outcome [1] 322723 0
Overall incidence of nausea as measured by a 10 mm visual analogue scale to determine nausea severity with 0-1 indicating no nausea, >1-4 mild, >4-7 moderate and >7-10 severe nausea.
Timepoint [1] 322723 0
At 24 hours post-surgery.
Primary outcome [2] 323111 0
Overall incidence vomiting (which includes both retching and vomiting)
Timepoint [2] 323111 0
At 24 hours post-operation.
Secondary outcome [1] 379470 0
Incidence of nausea as measured by a 10 mm visual analogue scale to determine nausea severity with 0-1 indicating no nausea, >1-4 mild, >4-7 moderate and >7-10 severe nausea.
Timepoint [1] 379470 0
At 0-2hrs, 2-6hrs, 6-24hrs and 24-48hrs post-operation.
Secondary outcome [2] 379471 0
Severity of nausea as measured by the 100mm visual analogue scale
Timepoint [2] 379471 0
At 0-2hrs, 2-6hrs, 6-24hrs and 24-48hrs post-operation.
Secondary outcome [3] 379472 0
Need for a rescue antiemetic with further boluses of cyclizine 25mg or droperidol 0.625mg TDS PRN as assessed by patient medical records during hospital stay.
Timepoint [3] 379472 0
At 0-2hrs, 2-6hrs, 6-24hrs and 24-48 hrs post-operation.
Secondary outcome [4] 379473 0
Treatment costs associated with patient's length of stay at hospital as extracted by a Clinical Costing Analyst of the Decision Support Unit. These costs include: -
- theatre
- imaging
- nursing
- pathology
- allied health
- non allied health
- pharmacy
- Emergency
- Med Non Surgery
- Surgery
- PBS

We are looking to compare the in hospital costs of patients who've received intervention vs. placebo.
Timepoint [4] 379473 0
At day of discharge
Secondary outcome [5] 379474 0
Hospital length of stay
Timepoint [5] 379474 0
At discharge
Secondary outcome [6] 379475 0
Adverse events including headache as assessed self-reported by patient via questionnaire designed specifically for this study.
Timepoint [6] 379475 0
At any time during hospital stay
Secondary outcome [7] 379476 0
The efficacy of the treatment arms in terms of QoL and functional impact will be assessed by adopting the Functional Living Index – Emesis (FLIE) questionnaire
Timepoint [7] 379476 0
At discharge
Secondary outcome [8] 380845 0
Incidence of vomiting
Timepoint [8] 380845 0
At 0-2hrs, 2-6hrs, 6-24hrs and 24-48hrs post-surgery.
Secondary outcome [9] 380848 0
Adverse events including dizziness as assessed by patient medical records during hospital stay.
Timepoint [9] 380848 0
At anytime during hospital stay
Secondary outcome [10] 380849 0
Adverse events including dyspepsia as assessed by patient medical records during hospital stay.
Timepoint [10] 380849 0
At anytime during hospital stay.
Secondary outcome [11] 380850 0
Adverse events including QT prolongation as assessed by patient medical records during hospital stay.
Timepoint [11] 380850 0
At anytime during hospital stay.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size was predetermined using a power analysis based on the assumptions of a 35% incidence of PONV in the control group and 25% risk reduction in PONV due to Akynzeo. The minimum required sample size is 80 patients for each surgical group (laparosopic sleeve gastrectomy or roux-en-Y gastric bypass (40 in each group) to achieve 80% power (ß = 0.2) and 5% significance level (a = 0.05). A total of 160 patients will be recruited for this study.

Statistical Methods
Statistical analysis will be performed using Stata 9.0 (College Station, TX, USA) using an intention-to-treat model. Normally distributed continuous data will be compared using Student’s t test while categorical data will be compared using chi-square test and Fisher’s exact test. Time to first emetic event and first use of rescue medication will be summarized using Kaplan-Meier curves. Differences will be considered significant at p < 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2020
Actual
3/02/2021
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
3/07/2023
Actual
Sample size
Target
160
Accrual to date
96
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15743 0
St Vincent's Private Hospital - Fitzroy
Recruitment hospital [2] 24328 0
Epworth Freemasons (Clarendon Street) - East Melbourne
Recruitment postcode(s) [1] 39884 0
3002 - East Melbourne
Recruitment postcode(s) [2] 29173 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 304842 0
Hospital
Name [1] 304842 0
St Vincent's Hospital Melbourne Research Endowment Fund
Country [1] 304842 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
41 Victoria Parade
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 305178 0
None
Name [1] 305178 0
Address [1] 305178 0
Country [1] 305178 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305252 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 305252 0
41 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 305252 0
Australia
Date submitted for ethics approval [1] 305252 0
30/04/2020
Approval date [1] 305252 0
01/07/2020
Ethics approval number [1] 305252 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99774 0
Dr Romy Granek
Address 99774 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
Country 99774 0
Australia
Phone 99774 0
+61412142106
Fax 99774 0
Email 99774 0
romy.granek@gmail.com
Contact person for public queries
Name 99775 0
Dr Lynn chong
Address 99775 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
Country 99775 0
Australia
Phone 99775 0
+61 3 92312074
Fax 99775 0
Email 99775 0
lynn.chong@svha.org.au
Contact person for scientific queries
Name 99776 0
Dr Romy Granek
Address 99776 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
Country 99776 0
Australia
Phone 99776 0
+61 3 9231 2211
Fax 99776 0
Email 99776 0
romy.granek@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Investigators preference.


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.