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NCT04461093
Comparison of the Efficacy of Acupressure P6 Point, Dexamethasone and Ondansetron Versus Palonosetron Monotherapy for Preventing Postoperative Nausea and Vomiting in Laparoscopic Surgery
NA trial testing Acupressure wristband and Palanosetron in Palonosetron in 90 participants. Completed in 1 November 2021.
1 November 2021
Quick facts
| Lead sponsor | Mohd Zulfakar Mazlan, MBBS |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 6 July 2020 |
| Primary completion | 1 November 2021 |
| Estimated completion | 1 November 2021 |
| Sites | 2 locations across Malaysia |
Drugs / interventions tested
- Acupressure wristband and Palanosetron
Conditions studied
- Palonosetron — all drugs for Palonosetron →
Sponsor
Mohd Zulfakar Mazlan, MBBS
Who can join
Adults 18 to 65, any sex, with Palonosetron. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04461093
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Related trials
Other Mohd Zulfakar Mazlan, MBBS trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04461093 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mohd Zulfakar Mazlan, MBBS
- Last refreshed: 1 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04461093.
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