An interventional study of Acupressure wristband and Palanosetron in Palonosetron, sponsored by Mohd Zulfakar Mazlan, MBBS. Completed at 2 sites in Malaysia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-01.
Sponsored by Mohd Zulfakar Mazlan, MBBS · Not applicable, Interventional, and Treatment
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.
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.
1,100 studies on the registry are indexed under Vomiting; 134 are open to participants now.
This study's enrollment of 90 is below the median of 107 across 935 interventional studies indexed under Vomiting.
Browse Vomiting studies →Mohd Zulfakar Mazlan, MBBS is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group I (n=45) 1. Acupressure wristband 2. IV Dexamethasone 8mg 3. IV Ondansetron 4mg
Other: Acupressure wristband and Palanosetron
Group II (n=45) 1. IV Palonosetron 0.075mg
Other: Acupressure wristband and Palanosetron
Group 1 Patients with odd numbers labelled form will be Group I patients. They will receive intravenous dexamethasone 8mg during induction. Acupressure P6 wristband is applied after induction and removed prior to emergence to maintain blinding. Intravenous ondansetron 4mg is given prior to skin closure. Group 11 Patients with even numbers labelled form will be Group II patients who will receive intravenous palonosetron 0.075mg during induction.
The incidence of postoperative nausea and vomiting immediately, at
Time frame: Hours 6, postoperative.
The incidence of postoperative nausea and vomiting immediately, at
Time frame: Hours 12, postoperative
The incidence of postoperative nausea and vomiting immediately, at
Time frame: Hours 24, postoperative
The incidence of postoperative nausea and vomiting immediately, at
Time frame: Hours 48, postoperative
The proportion of patients require rescue anti-emetics immediately,
Time frame: at Hours 6, postoperative.
The proportion of patients require rescue anti-emetics immediately,
Time frame: Hours 12, postoperative.
The proportion of patients require rescue anti-emetics immediately,
Time frame: Hours 24, postoperative.
The proportion of patients require rescue anti-emetics immediately,
Time frame: Hours 48, postoperative.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mohd Zulfakar Mazlan, MBBS