Post-Operative Therapy for Nausea or Vomiting

Nausea Clinical Trial

Official title:

Optimization of Post-Operative Therapy for Nausea or Vomiting

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03075163
• Other study ID #: 932163
• Status: Terminated
• Phase: Phase 4
• Start date: October 18, 2016
• Est. completion date: December 2018

Study information

• Verified date: June 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: December 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for elective surgery requiring general anesthesia

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Nausea
• Vomiting

Intervention

Procedure:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
United States	UC Davis Health	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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, Tramèr 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. — View Citation

Genç 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. — View Citation

Hirsch J. Impact of postoperative nausea and vomiting in the surgical setting. Anaesthesia. 1994 Jan;49 Suppl:30-3. Review. — View Citation

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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2015;11:CD003281. — View Citation

Liodden I, Howley M, Grimsgaard AS, Fønnebø 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. — View Citation

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. — View Citation

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. — View Citation

Tokumaru O, Chen JD. Effects of acupressure on gastric myoelectrical activity in healthy humans. Scand J Gastroenterol. 2005 Mar;40(3):319-25. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Time to discharge from post anesthetic care unit

External Links

•   Ondansetron
•   Postoperative nausea and vomiting - a narrative review of pathophysiology, pharmacotherapy and clinical management strategies