Optimization of Post-Operative Therapy for Nausea or Vomiting

Post-Operative Therapy for Nausea or Vomiting

Sponsors

Lead sponsor: University of California, Davis

Source 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.

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.

Overall Status Terminated
Start Date October 18, 2016
Completion Date December 2018
Primary Completion Date April 2017
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Nausea Score Time to discharge from post anesthetic care unit
Enrollment 300
Condition
Intervention

Intervention type: Procedure

Intervention name: Acupressure

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.

Arm group label: Acupressure

Intervention type: Drug

Intervention name: Ondansetron

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.

Arm group label: Ondansetron

Other name: Zofran

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Location
facility
UC Davis Health
Location Countries

United States

Verification Date

June 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Acupressure

Arm group type: Experimental

Description: Manual pressure will be applied on the wrists bilaterally.

Arm group label: Ondansetron

Arm group type: Active Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov