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Trial · NCT02473042

Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)

NCT02473042, Not applicable, Completed, M.D. Anderson Cancer Center; results first posted 2025-12-05

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV). Trials, record NCT02473042. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02473042

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)
NCT number
NCT02473042
Status
Completed
Phases
Not applicable
Enrollment
188 participants, actual
Lead sponsor
M.D. Anderson Cancer Center
Conditions
Post-Operative Nausea and Vomiting, Breast Cancer
Interventions
Electrical Stimulation, Zofran, Dexamethasone, Phenergan, Pepcid, Questionnaire
First posted
2015-06-16
Last updated
2025-12-05
Results first posted
2025-12-05

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryEfficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV)During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
Examine the efficacy of electrical stimulation of P6 combined with prophylactic anti-emetics versus pharmacological prophylaxis alone in preventing the incidence of PONV following breast surgery in patients at high-risk for PONV Complete control is defined as "No nausea≥3 \& No vomiting \& No use of anti-emetic during PACU stay"
SecondaryFeasibility of Conducting StudyAt study consent and at PACU discharge
Determine the study feasibility where feasibility is defined by at least 20% of screened patients meeting inclusion criteria ability, 50% of these patients consenting, and 75% of patients within the acupuncture study arm completing all procedures
SecondaryEfficacy of Intervention to Prevent Need for Rescue Anti-emeticsDuring stay in post-operative anesthesia care unit, until discharge, an average of 1 dayExamine the effects of intra-operative NMBM stimulation of P6 on whether or not any anti-emetics were used compared to the control group
SecondarySatisfactionAt discharge from post-operative anesthesia care unit
Examine group differences in post-operative patient satisfaction with PONV management. Participants were asked to rate their satisfaction with their nausea and vomiting management on a scale of 0-10, where "0" equals "very dissatisfied", and "10" equals "extremely satisfied".
SecondaryEfficacy of Intervention to Result in Decreased PACU Length-of-stayDuring stay in post-operative anesthesia care unit, until discharge, an average of 1 dayExplore if intra-operative NMBM stimulation of P6 results in decreased PACU length-of-stay
SecondaryExpectancyBaseline
Explore the associations between expectancy and response to P6 stimulation. Step 1 of 2 compares expectancy answers between groups. The expectancy questionnaire asks participants what their expectation is of the effects of the intervention on lowering their nausea after surgery, lowering their pain after surgery, enabling them to cope with nausea and/or pain better, and enabling them to have a better recovery after surgery. Possible answers are "Not at all agree", "A little agree", "Moderately agree", "Mostly agree", and "Completely agree".
SecondaryExpectancy and Response to P6 StimulationDuring stay in post-operative anesthesia care unit, until discharge
Explore the associations between expectancy and response to P6 stimulation. Step 2 of 2 compares baseline expectancy answers and response to P6 stimulation outcome directly, without taking into account group assignment. The P6 stimulation outcome was categorized as "Fail" or "Success", where "Success" is defined as "No nausea≥3 \& No vomiting \& No use of anti-emetic during PACU stay".

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYEfficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV)During stay in post-operative anesthesia care unit, until discharge, an average of 1 dayParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYFeasibility of Conducting StudyAt study consent and at PACU discharge
Feasibility was defined in three different ways, and in accordance with each feasibility definition type, there was a different number of patients analyzed. Per protocol, for the completed study feasibility definition, we were only looking at the intervention arm. We were not looking at both arms.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYEfficacy of Intervention to Prevent Need for Rescue Anti-emeticsDuring stay in post-operative anesthesia care unit, until discharge, an average of 1 dayNumber of participants analyzed does not match number of participants who completed in participant flow due to missing dataParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYSatisfactionAt discharge from post-operative anesthesia care unitNumber of participants analyzed does not match number of participants who completed in participant flow due to missing dataSatisfaction scoreMEAN
SECONDARYEfficacy of Intervention to Result in Decreased PACU Length-of-stayDuring stay in post-operative anesthesia care unit, until discharge, an average of 1 daynumber of minutesMEAN
SECONDARYExpectancyBaselineParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYExpectancy and Response to P6 StimulationDuring stay in post-operative anesthesia care unit, until discharge
The statistical analysis was between expectancy response at baseline and response to P6 stimulation outcome of either fail or success during PACU stay until discharge, regardless of group assignment. Number of participants analyzed does not match number of participants who completed in participant flow due to missing data for the P6 stimulation outcome.
ParticipantsCOUNT_OF_PARTICIPANTS

Results by group89

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV)InterventionFail19Participants
Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV)ControlFail12Participants
Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV)InterventionSuccess67Participants
Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV)ControlSuccess71Participants
Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV)InterventionMissing Information0Participants
Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV)ControlMissing Information3Participants
Feasibility of Conducting StudyEntire StudyScreened eligible233Participants
Feasibility of Conducting StudyEntire StudyConsented188Participants
Feasibility of Conducting StudyEntire StudyCompleted study86Participants
Efficacy of Intervention to Prevent Need for Rescue Anti-emeticsInterventionNo45Participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDIntervention92
Overall StudySTARTEDControl92
Overall StudyCOMPLETEDIntervention86
Overall StudyCOMPLETEDControl86
Overall StudyNOT COMPLETEDIntervention6
Overall StudyNOT COMPLETEDControl6

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherMuscle weakness upper limb [left]Musculoskeletal and connective tissue disordersIntervention186
otherMuscle weakness upper limb [left]Musculoskeletal and connective tissue disordersControl286
otherMuscle weakness upper limb [right]Musculoskeletal and connective tissue disordersIntervention086
otherMuscle weakness upper limb [right]Musculoskeletal and connective tissue disordersControl386
otherNumbness in left armNervous system disordersIntervention186
otherNumbness in left armNervous system disordersControl286
otherNumbness in right armNervous system disordersIntervention086
otherNumbness in right armNervous system disordersControl186
otherPain in extremityMusculoskeletal and connective tissue disordersIntervention086
otherPain in extremityMusculoskeletal and connective tissue disordersControl186

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityIntervention086
Total, all-cause mortalityControl086
Total, other adverse eventsIntervention486
Total, other adverse eventsControl1186
Total, serious adverse eventsIntervention086
Total, serious adverse eventsControl086

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Intervention vs Control: deaths from any causeTrial comparisons
Intervention vs Control: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02473042

GET https://conductscience.org/api/trials/v1/NCT02473042/results?page=2