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recruitment futility
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupressure | Experimental | Manual pressure will be applied on the wrists bilaterally. |
|
| Ondansetron | Active Comparator | Ondansetron (Zofran) is used for the treatment of nausea and vomiting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupressure | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Time to discharge from post anesthetic care unit |
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Inclusion Criteria:
- Patients scheduled for elective surgery requiring general anesthesia
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Marc, MD, PhD | University of CA, Davis | Principal Investigator |
| Neal W Fleming, MD, PhD | University of CA, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Health | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22223185 | Background | 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. | |
| 22156268 | Background | Chandrakantan 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. |
| Label | URL |
|---|---|
| Ondansetron | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acupressure | Manual pressure will be applied on the wrists bilaterally. Acupressure: 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. |
| FG001 | Ondansetron | Ondansetron (Zofran) is used for the treatment of nausea and vomiting. Ondansetron: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acupressure | Manual pressure will be applied on the wrists bilaterally. Acupressure: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Error | score on a scale | Time to discharge from post anesthetic care unit |
|
Time from completion of the surgical procedure and arrival in the post anesthetic care unit until discharge from the post anesthesia care unit
Data collected from chart review
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acupressure | Manual pressure will be applied on the wrists bilaterally. Acupressure: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neal Fleming, MD, PhD | UC Davis Anesthesiology & Pain Medicine | 916 734-5046 | nwfleming@ucdavis.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2016 | May 13, 2019 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| D009325 | Nausea |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D019050 | Acupressure |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| Ondansetron | Drug | 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. |
|
|
| 8129160 | Background | Hirsch 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. |
| 18042859 | Background | Gan 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. |
| 22504214 | Background | White 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. |
| 19370583 | Background | Lee 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. |
| 21169634 | Background | Liodden 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. |
| 22950829 | Background | Alessandrini 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. |
| 23605600 | Background | Noroozinia 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. |
| 24787745 | Background | Genc 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. |
| 15844844 | Background | Huang 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. |
| 15934175 | Background | Tokumaru 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. |
| BG001 | Ondansetron | Ondansetron (Zofran) is used for the treatment of nausea and vomiting. Ondansetron: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Ondansetron | Ondansetron (Zofran) is used for the treatment of nausea and vomiting. Ondansetron: 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. |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Ondansetron | Ondansetron (Zofran) is used for the treatment of nausea and vomiting. Ondansetron: 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. | 0 | 12 | 0 | 12 | 0 | 12 |
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| D010335 | Pathologic Processes |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |