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Post-Operative Therapy for Nausea or Vomiting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03075163
Recruitment Status : Terminated (recruitment futility)
First Posted : March 9, 2017
Results First Posted : June 4, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Vomiting Nausea Procedure: Acupressure Drug: Ondansetron Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimization of Post-Operative Therapy for Nausea or Vomiting
Actual Study Start Date : October 18, 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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 Name: Zofran




Primary Outcome Measures :
  1. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075163


Locations
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United States, California
UC Davis Health
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Paul Marc, MD, PhD University of CA, Davis
Principal Investigator: Neal W Fleming, MD, PhD University of CA, Davis
  Study Documents (Full-Text)

Documents provided by University of California, Davis:
Study Protocol  [PDF] October 12, 2016
No Statistical Analysis Plan (SAP) exists for this study.

Additional Information:
Publications:

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03075163    
Other Study ID Numbers: 932163
First Posted: March 9, 2017    Key Record Dates
Results First Posted: June 4, 2019
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
PONV
Nausea
Vomiting
Acupressure
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents