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Post-Operative Therapy for Nausea or Vomiting

Primary Purpose

Vomiting, Nausea

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acupressure
Ondansetron
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vomiting focused on measuring PONV, Nausea, Vomiting, Acupressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Davis Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acupressure

Ondansetron

Arm Description

Manual pressure will be applied on the wrists bilaterally.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 11, 2017
Last Updated
June 4, 2019
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03075163
Brief Title
Post-Operative Therapy for Nausea or Vomiting
Official Title
Optimization of Post-Operative Therapy for Nausea or Vomiting
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
recruitment futility
Study Start Date
October 18, 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vomiting, Nausea
Keywords
PONV, Nausea, Vomiting, Acupressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupressure
Arm Type
Experimental
Arm Description
Manual pressure will be applied on the wrists bilaterally.
Arm Title
Ondansetron
Arm Type
Active Comparator
Arm Description
Ondansetron (Zofran) is used for the treatment of nausea and vomiting.
Intervention Type
Procedure
Intervention Name(s)
Acupressure
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Zofran
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Nausea Score
Description
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 Frame
Time to discharge from post anesthetic care unit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Marc, MD, PhD
Organizational Affiliation
University of CA, Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neal W Fleming, MD, PhD
Organizational Affiliation
University of CA, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22223185
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.
Results Reference
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PubMed Identifier
22156268
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.
Results Reference
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PubMed Identifier
8129160
Citation
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.
Results Reference
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PubMed Identifier
18042859
Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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.
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PubMed Identifier
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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.
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PubMed Identifier
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Citation
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.
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PubMed Identifier
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Citation
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Citation
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Results Reference
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Links:
URL
https://medlineplus.gov/druginfo/meds/a601209.html
Description
Ondansetron

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Post-Operative Therapy for Nausea or Vomiting

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