NauseaNCT01317082
Use of the Pressure Right Device After Laparoscopic Surgery
A study testing Acupressure in people with Nausea and Vomiting, run by Therapeutics: 101 Inc..
Trial summary
The primary objective is to test the hypothesis that the use of the Pressure Right device in combination with ondansetron and dexamethasone would result in a lower incidence of postoperative vomiting (emesis) than the combination of antiemetic therapy alone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Acupressure
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo major laparoscopic and ENT surgery procedures under genertal anesthesia.
- ASA Class I-III adults of either sex
- Willingness and ability to sign an informed consent document.
Who cannot join
- Patients with known allergy, hypersensitivity or contraindications to 5-HT3 antagonist.
- Patients experienced vomiting or retching within 24 h before surgery.
- Patients with clinically-significant medical conditions.
- Pregnant and lactating women.
About this study
The primary objective is to test the hypothesis that the use of the Pressure Right device in combination with ondansetron and dexamethasone would result in a lower incidence of postoperative vomiting (emesis) than the combination of antiemetic therapy alone.
Read the detailed description
The study design is a randomized, double-blinded and sham-controlled evaluation of the adjunctive Acupressure on the P6 point with Pressure Right to reduce the incidence of PONV and the need for rescue antiemetics leading to an improve quality of recovery after laparoscopic and ENT surgery. The two proposed study groups are: Group 1 (Sham-Control) 50 patients, will receive the sham Pressure Right (without acupressure button)30-45 min before induction of anesthesia and will be kept in place for 24h after discharge, and Group 2 (Pressure Right) 50 patients, will receive the Pressure Right device 30-45 min before induction of anesthesia and will be kept in place for 24h after discharge. In addition, all 100 study patients will receive a combination of antiemetics (ondansetron and dexamethasone) during the surgery.
- Being tested
- Acupressure
- Keywords
- Postoperative Nausea & Vomiting.
- Medical subject headings
- Nausea, Vomiting, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureDevice
Also called Pressure Right
P 6 Pressure Point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Therapeutics: 101 Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317082
- Sponsor's protocol ID
- JDL20-11
- Status last verified
- Feb 2011
- First submitted
- 15 Mar 2011
- Last updated
- 17 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Pressure Right Device After Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01317082
- Acronym / sponsor ID
- JDL20-11
- Keywords
- Postoperative Nausea & Vomiting.
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Therapeutics: 101 Inc.Industry (pharma, biotech, devices)
- First posted
- 17 Mar 2011 (estimated)
- 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.
The primary objective is to test the hypothesis that the use of the Pressure Right device in combination with ondansetron and dexamethasone would result in a lower incidence of postoperative vomiting (emesis) than the combination of antiemetic therapy alone.
Detailed description
The study design is a randomized, double-blinded and sham-controlled evaluation of the adjunctive Acupressure on the P6 point with Pressure Right to reduce the incidence of PONV and the need for rescue antiemetics leading to an improve quality of recovery after laparoscopic and ENT surgery. The two proposed study groups are: Group 1 (Sham-Control) 50 patients, will receive the sham Pressure Right (without acupressure button)30-45 min before induction of anesthesia and will be kept in place for 24h after discharge, and Group 2 (Pressure Right) 50 patients, will receive the Pressure Right device 30-45 min before induction of anesthesia and will be kept in place for 24h after discharge. In addition, all 100 study patients will receive a combination of antiemetics (ondansetron and dexamethasone) during the surgery.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled to undergo major laparoscopic and ENT surgery procedures under genertal anesthesia.
- ASA Class I-III adults of either sex
- Willingness and ability to sign an informed consent document.
Key exclusion criteria (4 listed)
- Patients with known allergy, hypersensitivity or contraindications to 5-HT3 antagonist.
- Patients experienced vomiting or retching within 24 h before surgery.
- Patients with clinically-significant medical conditions.
- Pregnant and lactating women.
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 |
|---|---|---|
| AcupressureAlso: Pressure RightP 6 Pressure Point | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2011.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure in people with Nausea and Vomiting, run by Therapeutics: 101 Inc..
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 4 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: status not confirmed, as of the sponsor's last update on 17 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
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 17 Mar 2011.