Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04461093 |
Other study ID # |
PalanosetronUSM |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 6, 2020 |
Est. completion date |
November 1, 2021 |
Study information
Verified date |
April 2024 |
Source |
Universiti Sains Malaysia |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Postoperative nausea and vomiting (PONV) is defined as nausea and/or vomiting occurring
within 24 hours after surgery, it commonly affects 20-30% patients but as high as 70-80%
patients who are deemed high risk for PONV may be affected. PONV may cause unpleasant
complications such as dehydration, electrolyte imbalance, suture dehiscence, aspiration of
gastric contents, delayed recovery and prolonged hospital stay. Standard guideline
recommended combination of anti-emetics to prevent PONV in high risk patients. The commonly
used agents are dexamethasone and ondansetron which are cheaper although they are proven to
be less effective as single agent when compared with newer agent such as palonosetron. As an
adjunct or alternative to pharmacological treatment, acupressure P6 point has gained
increasing attention for its possible value in preventing PONV. It is proven that acupressure
reduced the incidences of PONV when combined with pharmacological treatment. It is postulated
that acupressure active Aβ and Aδ fibres and stimulate the release of β-endorphine from
hypothalamus. In addition, it is believed that acupressure might act on dopaminergic,
serotonergic and norepinerphrinergic fibres which might has a role in PONV prevention.
Description:
This study is designed to compare the efficacy of palonosetron monotherapy versus combination
of acupressure P6 point with dexamethasone and ondansetron in preventing PONV. It has been
proven that palonosetron is more superior as single agent when compared with acupressure,
dexamethasone and ondansetron separately. However, this might not be cost effective as
palonosetron is more expensive than the other agents. In addition, the combination therapy
has been reported better in preventing PONV when compared with monotherapy. The investigators
need to investigate whether the combination of acupressure with dexamethasone and ondansetron
exert an effect equal or even better than palonosetron monotherapy. The investigators
hypothesis is the combination of acupressure P6 point with dexamethasone and ondansetron
provide better prophylaxis againts PONV when compared with palonosetron. The requirement for
rescue anti-emetics for combination of acupressure P6 point with dexamethasone and
ondansetron group is lesser than palonosetron.