Post-Operative Therapy for Nausea or Vomiting

Phase 4

Terminated

• Conditions: Vomiting; Nausea
• Interventions: Procedure: Acupressure; Drug: Ondansetron

• Registration Number: NCT03075163
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2016-10-18
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-09
• Primary Completion: 2017-04
• Study Completion: 2018-12
• Results First Submitted: 2019-04-18
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-03
• Results First Posted: 2019-06-04
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupressure	Acupressure	Manual pressure will be applied on the wrists bilaterally.
Ondansetron	Ondansetron	Ondansetron (Zofran) is used for the treatment of nausea and vomiting.

Primary Outcome Measures

Name	Time	Method
Change in Nausea Score	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

Trial Locations

Locations (1)

UC Davis Health; 🇺🇸 Sacramento, California, United States