Post-Operative Therapy for Nausea or Vomiting

June 4, 2019 updated by: University of California, Davis

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupressure
Manual pressure will be applied on the wrists bilaterally.
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.
Active Comparator: Ondansetron
Ondansetron (Zofran) is used for the treatment of nausea and vomiting.
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.
Other Names:
  • Zofran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time to discharge from post anesthetic care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Paul Marc, MD, PhD, University of CA, Davis
  • Principal Investigator: Neal W Fleming, MD, PhD, University of CA, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

March 3, 2017

First Posted (Actual)

March 9, 2017

Study Record Updates

Last Update Posted (Actual)

June 18, 2019

Last Update Submitted That Met QC Criteria

June 4, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 932163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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