Post-Operative Therapy for Nausea or Vomiting

NCT03075163 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 932163
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vomiting; Nausea

Keywords

PONV; Nausea; Vomiting; Acupressure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Acupressure

EXPERIMENTAL

Manual pressure will be applied on the wrists bilaterally.

Procedure: Acupressure

Ondansetron

ACTIVE COMPARATOR

Ondansetron (Zofran) is used for the treatment of nausea and vomiting.

Drug: Ondansetron

Interventions

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.

Acupressure

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.

Also known as: Zofran

Ondansetron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients scheduled for elective surgery requiring general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Health

Sacramento, California, 95817, United States

Location

Related Publications (12)

• 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.

  PMID: 22223185 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.

  PMID: 22156268 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.

  PMID: 8129160 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.

  PMID: 18042859 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.

  PMID: 22504214 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.

  PMID: 19370583 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.

  PMID: 21169634 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.

  PMID: 22950829 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.

  PMID: 23605600 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.

  PMID: 24787745 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.

  PMID: 15844844 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.

  PMID: 15934175 BACKGROUND

Related Links

• Ondansetron

MeSH Terms

Conditions

Vomiting; Nausea; Postoperative Nausea and Vomiting

Interventions

Acupressure; Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Neal Fleming, MD, PhD
• Organization: UC Davis Anesthesiology & Pain Medicine

nwfleming@ucdavis.edu

916 734-5046

Study Officials

• Paul Marc, MD, PhD

  University of CA, Davis

  PRINCIPAL INVESTIGATOR

• Neal W Fleming, MD, PhD

  University of CA, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: March 9, 2017
• Study Start: October 18, 2016
• Primary Completion: April 1, 2017
• Study Completion: December 1, 2018
• Last Updated: June 18, 2019
• Results First Posted: June 4, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)