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Post-Operative Therapy for Nausea or Vomiting

Optimization of Post-Operative Therapy for Nausea or Vomiting

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03075163
Enrollment
300
Registered
2017-03-09
Start date
2016-10-18
Completion date
2018-12-31
Last updated
2019-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea, Vomiting

Keywords

PONV, Nausea, Vomiting, Acupressure

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.

Interventions

PROCEDUREAcupressure

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.

DRUGOndansetron

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.

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Nausea ScoreTime to discharge from post anesthetic care unitDifference 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

Countries

United States

Participant flow

Participants by arm

ArmCount
Acupressure
Manual pressure will be applied on the wrists bilaterally. 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.
12
Ondansetron
Ondansetron (Zofran) is used for the treatment of nausea and vomiting. 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.
12
Total24

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studynot eligible for treatment limb138138

Baseline characteristics

CharacteristicAcupressureOndansetronTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
12 Participants12 Participants24 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
12 Participants12 Participants24 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
12 participants12 participants24 participants
Sex: Female, Male
Female
10 Participants9 Participants19 Participants
Sex: Female, Male
Male
2 Participants3 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 120 / 12
other
Total, other adverse events
0 / 120 / 12
serious
Total, serious adverse events
0 / 120 / 12

Outcome results

Primary

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

Time frame: Time to discharge from post anesthetic care unit

ArmMeasureValue (MEAN)Dispersion
AcupressureChange in Nausea Score1.88 score on a scaleStandard Error 1.8
OndansetronChange in Nausea Score1.25 score on a scaleStandard Error 2.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026