VomitingPhase 4NCT03075163
Post-Operative Therapy for Nausea or Vomiting
A Phase 4 study testing Acupressure and Ondansetron in people with Vomiting and Nausea, run by University of California, Davis at 1 site in United States.
Trial summary
This is a single site, prospective, randomized controlled study designed to evaluate the impact of acupressure when used as an initial treatment before rescue medications in the treatment of post-operative nausea and/or vomiting at UCD. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Acupressure and Ondansetron
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2016to Dec 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective surgery requiring general anesthesia
Who cannot join
- Age less than 18 years
- Adults unable to give primary consent
- Pregnancy
- Prisoners
- Unable to access pericardial 6 acupressure point bilaterally post procedure
- Allergy to Ondansetron
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of Post-Operative Therapy for Nausea or Vomiting
This is a single site, prospective, randomized controlled study designed to evaluate the impact of acupressure when used as an initial treatment before rescue medications in the treatment of post-operative nausea and/or vomiting at UCD.
Read the detailed description
Each individual will only participate in the post anesthetic care unit starting from when the patient's nurse or anesthesiology team deems that the patient needs treatment for PONV. It ends when the patient is discharged from anesthesiology care.
Patients will be asked to score nausea before randomized treatment of acupressure or medication, and to score nausea after treatment.
- Being tested
- Acupressure, Ondansetron
- Keywords
- PONV, Nausea, Vomiting, Acupressure
- Medical subject headings
- Vomiting, Nausea, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureProcedure or surgery
Specifically trained personnel will apply pressure on the wrists bilaterally at the P6 point for up to 3 minutes. The P6 point is located three fingerbreadths from the wrist crease on the volar surface of the arm between the palmaris longus and flexor carpi radialis.
In the event of failure in the acupressure group, further treatments will be identical to the control group. Since Ondansetron is the standard Post Anesthetic Care Unit treatment, it will be first line rescue therapy except in the case that the patient has received 8mg in the past 6 hours. If needed, further antiemetic pharmacologic treatments may include, but are not limited to, phenergan, metoclopramide, haloperidol, diphenhydramine or propofol at the clinical discretion of the patient's anesthesiology care team.
OndansetronDrug
Also called Zofran
Ondansetron is a medication that belongs to the drug class known as antiemetic and selective 5-HT3 receptor antagonist. Ondansetron is prescribed for the treatment of nausea and vomiting due to cancer chemotherapy and also used to prevent and treat nausea and vomiting after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure | Experimental | Manual pressure will be applied on the wrists bilaterally. Receives: Procedure: Acupressure |
| Ondansetron | Active comparator | Ondansetron (Zofran) is used for the treatment of nausea and vomiting. Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nausea Score
Difference in the nausea score before and after treatment. Nausea is scored on a scale from 1 to 10 with 1 being no nausea and 10 being severe nausea with impending vomiting.
A greater difference is indicative of a better outcome
Measured: Time to discharge from post anesthetic care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start18 Oct 2016
- Primary completionApr 2017
- Study completionDec 2018
Why it stopped: recruitment futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for VomitingStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Marc, MD, PhD, Principal investigator, University of CA, DavisNeal W Fleming, MD, PhD, Principal investigator, University of CA, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075163
- Sponsor's protocol ID
- 932163
- Status last verified
- Jun 2019
- First submitted
- 11 Jan 2017
- Last updated
- 18 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parra-Sanchez I, Abdallah R, You J, Fu AZ, Grady M, Cummings K 3rd, Apfel C, Sessler DI. A time-motion economic analysis of postoperative nausea and vomiting in ambulatory surgery. Can J Anaesth. 2012 Apr;59(4):366-75. doi: 10.1007/s12630-011-9660-x. Epub 2012 Jan 6.
PubMed 22223185Chandrakantan A, Glass PS. Multimodal therapies for postoperative nausea and vomiting, and pain. Br J Anaesth. 2011 Dec;107 Suppl 1:i27-40. doi: 10.1093/bja/aer358.
PubMed 22156268Hirsch J. Impact of postoperative nausea and vomiting in the surgical setting. Anaesthesia. 1994 Jan;49 Suppl:30-3. doi: 10.1111/j.1365-2044.1994.tb03580.x.
PubMed 8129160Gan TJ, Meyer TA, Apfel CC, Chung F, Davis PJ, Habib AS, Hooper VD, Kovac AL, Kranke P, Myles P, Philip BK, Samsa G, Sessler DI, Temo J, Tramer MR, Vander Kolk C, Watcha M; Society for Ambulatory Anesthesia. Society for Ambulatory Anesthesia guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2007 Dec;105(6):1615-28, table of contents. doi: 10.1213/01.ane.0000295230.55439.f4.
PubMed 18042859White PF, Zhao M, Tang J, Wender RH, Yumul R, Sloninsky AV, Naruse R, Kariger R, Cunneen S. Use of a disposable acupressure device as part of a multimodal antiemetic strategy for reducing postoperative nausea and vomiting. Anesth Analg. 2012 Jul;115(1):31-7. doi: 10.1213/ANE.0b013e3182536f27. Epub 2012 Apr 13.
PubMed 22504214Lee A, Fan LT. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003281. doi: 10.1002/14651858.CD003281.pub3.
PubMed 19370583Liodden I, Howley M, Grimsgaard AS, Fonnebo VM, Borud EK, Alraek T, Norheim AJ. Perioperative acupuncture and postoperative acupressure can prevent postoperative vomiting following paediatric tonsillectomy or adenoidectomy: a pragmatic randomised controlled trial. Acupunct Med. 2011 Mar;29(1):9-15. doi: 10.1136/aim.2010.002915. Epub 2010 Dec 18.
PubMed 21169634Alessandrini M, Napolitano B, Micarelli A, de Padova A, Bruno E. P6 acupressure effectiveness on acute vertiginous patients: a double blind randomized study. J Altern Complement Med. 2012 Dec;18(12):1121-6. doi: 10.1089/acm.2011.0384. Epub 2012 Sep 5.
PubMed 22950829Noroozinia H, Mahoori A, Hasani E, Gerami-Fahim M, Sepehrvand N. The effect of acupressure on nausea and vomiting after cesarean section under spinal anesthesia. Acta Med Iran. 2013 Apr 6;51(3):163-7.
PubMed 23605600Genc F, Tan M. The effect of acupressure application on chemotherapy-induced nausea, vomiting, and anxiety in patients with breast cancer. Palliat Support Care. 2015 Apr;13(2):275-84. doi: 10.1017/S1478951514000248. Epub 2014 Apr 30.
PubMed 24787745Huang ST, Chen GY, Lo HM, Lin JG, Lee YS, Kuo CD. Increase in the vagal modulation by acupuncture at neiguan point in the healthy subjects. Am J Chin Med. 2005;33(1):157-64. doi: 10.1142/S0192415X0500276X.
PubMed 15844844Tokumaru O, Chen JD. Effects of acupressure on gastric myoelectrical activity in healthy humans. Scand J Gastroenterol. 2005 Mar;40(3):319-25. doi: 10.1080/00365520410009636.
PubMed 15934175
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Post-Operative Therapy for Nausea or Vomiting
- ClinicalTrials.gov ID
- NCT03075163
- Acronym / sponsor ID
- 932163
- Keywords
- PONV, Nausea, Vomiting, Acupressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment futility
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 18 Oct 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Posted 4 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single site, prospective, randomized controlled study designed to evaluate the impact of acupressure when used as an initial treatment before rescue medications in the treatment of post-operative nausea and/or vomiting at UCD.
Detailed description
Each individual will only participate in the post anesthetic care unit starting from when the patient's nurse or anesthesiology team deems that the patient needs treatment for PONV. It ends when the patient is discharged from anesthesiology care.
Patients will be asked to score nausea before randomized treatment of acupressure or medication, and to score nausea after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupressure | Experimental | Procedure: AcupressureManual pressure will be applied on the wrists bilaterally. |
| Ondansetron | Active comparator | Drug: OndansetronOndansetron (Zofran) is used for the treatment of nausea and vomiting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for elective surgery requiring general anesthesia
Key exclusion criteria (6 listed)
- Age less than 18 years
- Adults unable to give primary consent
- Pregnancy
- Prisoners
- Unable to access pericardial 6 acupressure point bilaterally post procedure
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 |
|---|---|---|
| AcupressureSpecifically trained personnel will apply pressure on the wrists bilaterally at the P6 point for up to 3 minutes. The P6 point is located three fingerbreadths from the wrist crease on the volar surface of the arm between the palmaris longus and flexor carpi radialis. In the event of failure in the acupressure group, further treatments will be identical to the control group. Since Ondansetron is the standard Post Anesthetic Care Unit treatment, it will be first line rescue therapy except in the case that the patient has received 8mg in the past 6 hours. If needed, further antiemetic pharmacologic treatments may include, but are not limited to, phenergan, metoclopramide, haloperidol, diphenhydramine or propofol at the clinical discretion of the patient's anesthesiology care team. | Procedure or surgery | Acupressure |
| OndansetronAlso: ZofranOndansetron is a medication that belongs to the drug class known as antiemetic and selective 5-HT3 receptor antagonist. Ondansetron is prescribed for the treatment of nausea and vomiting due to cancer chemotherapy and also used to prevent and treat nausea and vomiting after surgery. | Drug | Ondansetron |
Primary outcome
Change in Nausea Score
Time frame: Time to discharge from post anesthetic care unit
Difference in the nausea score before and after treatment. Nausea is scored on a scale from 1 to 10 with 1 being no nausea and 10 being severe nausea with impending vomiting. A greater difference is indicative of a better outcome
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22223185Parra-Sanchez I, Abdallah R, You J, Fu AZ, Grady M, Cummings K 3rd, Apfel C, Sessler DI. A time-motion economic analysis of postoperative nausea and vomiting in ambulatory surgery. Can J Anaesth. 2012 Apr;59(4):366-75. doi: 10.1007/s12630-011-9660-x. Epub 2012 Jan 6.
- Background: PubMed 22156268Chandrakantan A, Glass PS. Multimodal therapies for postoperative nausea and vomiting, and pain. Br J Anaesth. 2011 Dec;107 Suppl 1:i27-40. doi: 10.1093/bja/aer358.
- Background: PubMed 8129160Hirsch J. Impact of postoperative nausea and vomiting in the surgical setting. Anaesthesia. 1994 Jan;49 Suppl:30-3. doi: 10.1111/j.1365-2044.1994.tb03580.x.
- Background: PubMed 18042859Gan TJ, Meyer TA, Apfel CC, Chung F, Davis PJ, Habib AS, Hooper VD, Kovac AL, Kranke P, Myles P, Philip BK, Samsa G, Sessler DI, Temo J, Tramer MR, Vander Kolk C, Watcha M; Society for Ambulatory Anesthesia. Society for Ambulatory Anesthesia guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2007 Dec;105(6):1615-28, table of contents. doi: 10.1213/01.ane.0000295230.55439.f4.
- Background: PubMed 22504214White PF, Zhao M, Tang J, Wender RH, Yumul R, Sloninsky AV, Naruse R, Kariger R, Cunneen S. Use of a disposable acupressure device as part of a multimodal antiemetic strategy for reducing postoperative nausea and vomiting. Anesth Analg. 2012 Jul;115(1):31-7. doi: 10.1213/ANE.0b013e3182536f27. Epub 2012 Apr 13.
- Background: PubMed 19370583Lee A, Fan LT. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003281. doi: 10.1002/14651858.CD003281.pub3.
- Background: PubMed 21169634Liodden I, Howley M, Grimsgaard AS, Fonnebo VM, Borud EK, Alraek T, Norheim AJ. Perioperative acupuncture and postoperative acupressure can prevent postoperative vomiting following paediatric tonsillectomy or adenoidectomy: a pragmatic randomised controlled trial. Acupunct Med. 2011 Mar;29(1):9-15. doi: 10.1136/aim.2010.002915. Epub 2010 Dec 18.
- Background: PubMed 22950829Alessandrini M, Napolitano B, Micarelli A, de Padova A, Bruno E. P6 acupressure effectiveness on acute vertiginous patients: a double blind randomized study. J Altern Complement Med. 2012 Dec;18(12):1121-6. doi: 10.1089/acm.2011.0384. Epub 2012 Sep 5.
- Background: PubMed 23605600Noroozinia H, Mahoori A, Hasani E, Gerami-Fahim M, Sepehrvand N. The effect of acupressure on nausea and vomiting after cesarean section under spinal anesthesia. Acta Med Iran. 2013 Apr 6;51(3):163-7.
- Background: PubMed 24787745Genc F, Tan M. The effect of acupressure application on chemotherapy-induced nausea, vomiting, and anxiety in patients with breast cancer. Palliat Support Care. 2015 Apr;13(2):275-84. doi: 10.1017/S1478951514000248. Epub 2014 Apr 30.
- Background: PubMed 15844844Huang ST, Chen GY, Lo HM, Lin JG, Lee YS, Kuo CD. Increase in the vagal modulation by acupuncture at neiguan point in the healthy subjects. Am J Chin Med. 2005;33(1):157-64. doi: 10.1142/S0192415X0500276X.
- Background: PubMed 15934175Tokumaru O, Chen JD. Effects of acupressure on gastric myoelectrical activity in healthy humans. Scand J Gastroenterol. 2005 Mar;40(3):319-25. doi: 10.1080/00365520410009636.
- OndansetronLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Paul Marc, MD, PhD principal investigator
University of CA, Davis
Neal W Fleming, MD, PhD principal investigator
University of CA, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acupressure and Ondansetron in people with Vomiting and Nausea, run by University of California, Davis at 1 site in United States.
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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Nausea Score (time frame: Time to discharge from post anesthetic care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03075163, which also lists 12 linked publications.
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 18 Jun 2019.