PalonosetronNCT04461093
Comparison of the Efficacy of Acupressure P6 Point, Dexamethasone and Ondansetron Versus Palonosetron Monotherapy for Preventing Postoperative Nausea and Vomiting in Laparoscopic Surgery
A study testing Acupressure wristband and Palanosetron in people with Palonosetron, run by Mohd Zulfakar Mazlan, MBBS at 2 sites in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Palonosetron
- What is being tested?
- Acupressure wristband and Palanosetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesMalaysia
- Study dates
- 6 Jul 2020to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I or II female patients aged 18 - 65 years old in view female patients are at higher risk of postoperative nausea and vomiting.
- Patients undergoing laparoscopic surgery.
- High risk for PONV (APFEL score 3-4).
Who cannot join
- Patients with known allergic to dexamethasone, ondansetron and wristband.
- Patients who take anti-emetic, emetogenic drugs and glucocorticoids within 24 hours before surgery.
- Patients with upper limb disability which affect the application of wristband.
- Obese patients with BMI > 35 in view acupressure P6 wristband might be too tight to fit patient's wrist which might affect the correct placement of pressure point.
- Pre-existing vertigo
Trial locations and contacts
2 sites in 1 country.
Malaysia2 sites
Mohd Zulfakar Mazlan, MBBS
Kota Bharu, Kelantan, 16150
Mohd Zulfakar Mazlan
Kota Bharu, Kelantan, 16150
About this study
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.
Read the detailed 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.
- Conditions
- Palonosetron
- Being tested
- Acupressure wristband and Palanosetron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure wristband and PalanosetronOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Group I (n=45)
1. Acupressure wristband
2. IV Dexamethasone 8mg
3. IV Ondansetron 4mg Receives: Other: Acupressure wristband and Palanosetron |
| Group II | Active comparator | Group II (n=45)
1. IV Palonosetron 0.075mg Receives: Other: Acupressure wristband and Palanosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative nausea and vomiting immediately, at
Measured: Hours 6, postoperative.
The incidence of postoperative nausea and vomiting immediately, at
Measured: Hours 12, postoperative
The incidence of postoperative nausea and vomiting immediately, at
Measured: Hours 24, postoperative
The incidence of postoperative nausea and vomiting immediately, at
Measured: Hours 48, postoperative
Secondary outcomes (4)
The proportion of patients require rescue anti-emetics immediately,
Measured: at Hours 6, postoperative.
The proportion of patients require rescue anti-emetics immediately,
Measured: Hours 12, postoperative.
The proportion of patients require rescue anti-emetics immediately,
Measured: Hours 24, postoperative.
The proportion of patients require rescue anti-emetics immediately,
Measured: Hours 48, postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start6 Jul 2020
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PalonosetronStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded, Randomized Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohd Zulfakar Mazlan, MBBS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohd Zulfakar Mazlan, MBBS, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461093
- Sponsor's protocol ID
- PalanosetronUSM
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2020
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Acupressure P6 Point, Dexamethasone and Ondansetron Versus Palonosetron Monotherapy for Preventing Postoperative Nausea and Vomiting in Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT04461093
- Acronym / sponsor ID
- PalanosetronUSM
- Conditions
- Palonosetron
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mohd Zulfakar Mazlan, MBBSUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded, Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Acupressure wristband and PalanosetronGroup I (n=45) 1. Acupressure wristband 2. IV Dexamethasone 8mg 3. IV Ondansetron 4mg |
| Group II | Active comparator | Other: Acupressure wristband and PalanosetronGroup II (n=45) 1. IV Palonosetron 0.075mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I or II female patients aged 18 - 65 years old in view female patients are at higher risk of postoperative nausea and vomiting.
- Patients undergoing laparoscopic surgery.
- High risk for PONV (APFEL score 3-4).
Key exclusion criteria (5 listed)
- Patients with known allergic to dexamethasone, ondansetron and wristband.
- Patients who take anti-emetic, emetogenic drugs and glucocorticoids within 24 hours before surgery.
- Patients with upper limb disability which affect the application of wristband.
- Obese patients with BMI > 35 in view acupressure P6 wristband might be too tight to fit patient's wrist which might affect the correct placement of pressure point.
- Pre-existing vertigo
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupressure wristband and PalanosetronGroup 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. | Other | Group I, Group II |
Primary outcome
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
4 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
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A Clinical Trial of HRS5580 for Injection Combined With Palonosetron Hydrochloride for the Prevention of Postoperative Nausea and Vomiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure wristband and Palanosetron in people with Palonosetron, run by Mohd Zulfakar Mazlan, MBBS at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative nausea and vomiting immediately, at (time frame: Hours 6, postoperative.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.