Trial Outcomes & Findings for Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV) (NCT NCT02473042)
NCT ID: NCT02473042
Last Updated: 2025-12-05
Results Overview
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"
COMPLETED
NA
188 participants
During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
2025-12-05
Participant Flow
The recruitment period occurred between March 2016 to June 2018. 609 potential patients were identified from the breast surgery schedule and were approached to assess their interest in participation and eligibility screening, of which, 233 patients met eligibility criteria. Of these 233 eligible patients, 188 patients consented to the trial.
Of the 188 consented patients, 184 patients were randomized. Four consented patients were excluded from trial before randomization due to: One patient became ineligible after enrollment, one patient's surgery started before study preparation could be completed, and two patients found to be ineligible after enrollment.
Participant milestones
| Measure |
Intervention
Anesthesiologist-provided intraoperative electrical stimulation of P6 with a neuromuscular blockade monitor, combined with prophylactic anti-emetics
|
Control
Only prophylactic anti-emetics
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
92
|
|
Overall Study
COMPLETED
|
86
|
86
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Intervention
Anesthesiologist-provided intraoperative electrical stimulation of P6 with a neuromuscular blockade monitor, combined with prophylactic anti-emetics
|
Control
Only prophylactic anti-emetics
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Patient became ineligible after enrollment
|
2
|
5
|
|
Overall Study
Surgery started before study preparation could be completed
|
0
|
1
|
|
Overall Study
PACU data unable to be collected
|
3
|
0
|
Baseline Characteristics
Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)
Baseline characteristics by cohort
| Measure |
Intervention
n=86 Participants
Anesthesiologist-provided intraoperative electrical stimulation of P6 with a neuromuscular blockade monitor, combined with prophylactic anti-emetics
|
Control
n=86 Participants
Only prophylactic anti-emetics
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.41 years
STANDARD_DEVIATION 10.32 • n=37 Participants
|
58.35 years
STANDARD_DEVIATION 11.71 • n=37 Participants
|
57.88 years
STANDARD_DEVIATION 11.02 • n=74 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=37 Participants
|
86 Participants
n=37 Participants
|
172 Participants
n=74 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=37 Participants
|
13 Participants
n=37 Participants
|
29 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=37 Participants
|
71 Participants
n=37 Participants
|
140 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=37 Participants
|
2 Participants
n=37 Participants
|
3 Participants
n=74 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=37 Participants
|
9 Participants
n=37 Participants
|
15 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=37 Participants
|
4 Participants
n=37 Participants
|
9 Participants
n=74 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=37 Participants
|
64 Participants
n=37 Participants
|
135 Participants
n=74 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=37 Participants
|
8 Participants
n=37 Participants
|
12 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
1 Participants
n=74 Participants
|
|
Region of Enrollment
United States
|
86 participants
n=37 Participants
|
86 participants
n=37 Participants
|
172 participants
n=74 Participants
|
PRIMARY outcome
Timeframe: During stay in post-operative anesthesia care unit, until discharge, an average of 1 dayExamine 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"
Outcome measures
| Measure |
Intervention
n=86 Participants
Anesthesiologist-provided intraoperative electrical stimulation of P6 with a neuromuscular blockade monitor, combined with prophylactic anti-emetics
|
Control
n=86 Participants
Only prophylactic anti-emetics
|
|---|---|---|
|
Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV)
Fail
|
19 Participants
|
12 Participants
|
|
Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV)
Success
|
67 Participants
|
71 Participants
|
|
Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV)
Missing Information
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: At study consent and at PACU dischargePopulation: 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.
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
Outcome measures
| Measure |
Intervention
n=609 Participants
Anesthesiologist-provided intraoperative electrical stimulation of P6 with a neuromuscular blockade monitor, combined with prophylactic anti-emetics
|
Control
Only prophylactic anti-emetics
|
|---|---|---|
|
Feasibility of Conducting Study
Screened eligible
|
233 Participants
|
—
|
|
Feasibility of Conducting Study
Consented
|
188 Participants
|
—
|
|
Feasibility of Conducting Study
Completed study
|
86 Participants
|
—
|
SECONDARY outcome
Timeframe: During stay in post-operative anesthesia care unit, until discharge, an average of 1 dayPopulation: Number of participants analyzed does not match number of participants who completed in participant flow due to missing data
Examine the effects of intra-operative NMBM stimulation of P6 on whether or not any anti-emetics were used compared to the control group
Outcome measures
| Measure |
Intervention
n=59 Participants
Anesthesiologist-provided intraoperative electrical stimulation of P6 with a neuromuscular blockade monitor, combined with prophylactic anti-emetics
|
Control
n=65 Participants
Only prophylactic anti-emetics
|
|---|---|---|
|
Efficacy of Intervention to Prevent Need for Rescue Anti-emetics
3
|
1 Participants
|
0 Participants
|
|
Efficacy of Intervention to Prevent Need for Rescue Anti-emetics
2
|
7 Participants
|
1 Participants
|
|
Efficacy of Intervention to Prevent Need for Rescue Anti-emetics
No
|
45 Participants
|
54 Participants
|
|
Efficacy of Intervention to Prevent Need for Rescue Anti-emetics
Yes
|
14 Participants
|
11 Participants
|
|
Efficacy of Intervention to Prevent Need for Rescue Anti-emetics
0
|
45 Participants
|
54 Participants
|
|
Efficacy of Intervention to Prevent Need for Rescue Anti-emetics
1
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: At discharge from post-operative anesthesia care unitPopulation: Number of participants analyzed does not match number of participants who completed in participant flow due to missing data
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".
Outcome measures
| Measure |
Intervention
n=83 Participants
Anesthesiologist-provided intraoperative electrical stimulation of P6 with a neuromuscular blockade monitor, combined with prophylactic anti-emetics
|
Control
n=76 Participants
Only prophylactic anti-emetics
|
|---|---|---|
|
Satisfaction
|
8.92 Satisfaction score
Standard Deviation 2.51
|
9.25 Satisfaction score
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: During 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
Outcome measures
| Measure |
Intervention
n=86 Participants
Anesthesiologist-provided intraoperative electrical stimulation of P6 with a neuromuscular blockade monitor, combined with prophylactic anti-emetics
|
Control
n=83 Participants
Only prophylactic anti-emetics
|
|---|---|---|
|
Efficacy of Intervention to Result in Decreased PACU Length-of-stay
|
120 number of minutes
Standard Deviation 53.07
|
119.46 number of minutes
Standard Deviation 49.88
|
SECONDARY outcome
Timeframe: BaselineExplore 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".
Outcome measures
| Measure |
Intervention
n=86 Participants
Anesthesiologist-provided intraoperative electrical stimulation of P6 with a neuromuscular blockade monitor, combined with prophylactic anti-emetics
|
Control
n=86 Participants
Only prophylactic anti-emetics
|
|---|---|---|
|
Expectancy
Response to ASES_Coping question: Missing
|
14 Participants
|
23 Participants
|
|
Expectancy
Response to ASES_Coping question: Not at all Agree/A little Agree
|
13 Participants
|
8 Participants
|
|
Expectancy
Response to ASES_Coping question: Moderately Agree
|
14 Participants
|
18 Participants
|
|
Expectancy
Response to ASES_Coping question: Mostly Agree/Completely Agree
|
45 Participants
|
37 Participants
|
|
Expectancy
Response to ASES_Nausea question: Not at all Agree/A little Agree
|
11 Participants
|
6 Participants
|
|
Expectancy
Response to ASES_Nausea question: Moderately Agree
|
18 Participants
|
17 Participants
|
|
Expectancy
Response to ASES_Nausea question: Mostly Agree/Completely Agree
|
43 Participants
|
40 Participants
|
|
Expectancy
Response to ASES_Nausea question: Missing
|
14 Participants
|
23 Participants
|
|
Expectancy
Response to ASES_Pain question: Not at all Agree/A little Agree
|
17 Participants
|
17 Participants
|
|
Expectancy
Response to ASES_Pain question: Moderately Agree
|
18 Participants
|
18 Participants
|
|
Expectancy
Response to ASES_Pain question: Mostly Agree/Completely Agree
|
37 Participants
|
29 Participants
|
|
Expectancy
Response to ASES_Pain question: Missing
|
14 Participants
|
23 Participants
|
|
Expectancy
Response to ASES_Recovery question: Not at all Agree/A little Agree
|
14 Participants
|
10 Participants
|
|
Expectancy
Response to ASES_Recovery question: Moderately Agree
|
13 Participants
|
12 Participants
|
|
Expectancy
Response to ASES_Recovery question: Mostly Agree/Completely Agree
|
45 Participants
|
42 Participants
|
|
Expectancy
Response to ASES_Recovery question: Missing
|
14 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: During stay in post-operative anesthesia care unit, until dischargePopulation: 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.
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".
Outcome measures
| Measure |
Intervention
n=31 Participants
Anesthesiologist-provided intraoperative electrical stimulation of P6 with a neuromuscular blockade monitor, combined with prophylactic anti-emetics
|
Control
n=138 Participants
Only prophylactic anti-emetics
|
|---|---|---|
|
Expectancy and Response to P6 Stimulation
Response to ASES_Coping question: Moderately Agree
|
6 Participants
|
25 Participants
|
|
Expectancy and Response to P6 Stimulation
Response to ASES_Coping question: Not at all Agree/A little Agree
|
6 Participants
|
15 Participants
|
|
Expectancy and Response to P6 Stimulation
Response to ASES_Coping question: Mostly Agree/Completely Agree
|
9 Participants
|
72 Participants
|
|
Expectancy and Response to P6 Stimulation
Response to ASES_Coping question: Missing
|
10 Participants
|
26 Participants
|
|
Expectancy and Response to P6 Stimulation
Response to ASES_Nausea question: Not at all Agree/A little Agree
|
5 Participants
|
12 Participants
|
|
Expectancy and Response to P6 Stimulation
Response to ASES_Nausea question: Moderately Agree
|
7 Participants
|
27 Participants
|
|
Expectancy and Response to P6 Stimulation
Response to ASES_Nausea question: Mostly Agree/Completely Agree
|
9 Participants
|
73 Participants
|
|
Expectancy and Response to P6 Stimulation
Response to ASES_Nausea question: Missing
|
10 Participants
|
26 Participants
|
|
Expectancy and Response to P6 Stimulation
Response to ASES_Pain question: Not at all Agree/A little Agree
|
7 Participants
|
27 Participants
|
|
Expectancy and Response to P6 Stimulation
Response to ASES_Pain question: Moderately Agree
|
5 Participants
|
30 Participants
|
|
Expectancy and Response to P6 Stimulation
Response to ASES_Pain question: Mostly Agree/Completely Agree
|
9 Participants
|
56 Participants
|
|
Expectancy and Response to P6 Stimulation
Response to ASES_Pain question: Missing
|
10 Participants
|
25 Participants
|
|
Expectancy and Response to P6 Stimulation
Response to ASES_Recovery question: Not at all Agree/A little Agree
|
7 Participants
|
17 Participants
|
|
Expectancy and Response to P6 Stimulation
Response to ASES_Recovery question: Moderately Agree
|
4 Participants
|
20 Participants
|
|
Expectancy and Response to P6 Stimulation
Response to ASES_Recovery question: Mostly Agree/Completely Agree
|
10 Participants
|
76 Participants
|
|
Expectancy and Response to P6 Stimulation
Response to ASES_Recovery question: Missing
|
10 Participants
|
25 Participants
|
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention
n=86 participants at risk
Anesthesiologist-provided intraoperative electrical stimulation of P6 with a neuromuscular blockade monitor, combined with prophylactic anti-emetics
|
Control
n=86 participants at risk
Only prophylactic anti-emetics
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb [left]
|
1.2%
1/86 • During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
|
2.3%
2/86 • During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb [right]
|
0.00%
0/86 • During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
|
3.5%
3/86 • During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
|
|
Nervous system disorders
Numbness in left arm
|
1.2%
1/86 • During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
|
2.3%
2/86 • During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
|
|
Nervous system disorders
Numbness in right arm
|
0.00%
0/86 • During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
|
1.2%
1/86 • During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/86 • During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
|
1.2%
1/86 • During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
|
|
Nervous system disorders
Paresthesia [left]
|
1.2%
1/86 • During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
|
1.2%
1/86 • During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
|
|
Nervous system disorders
Paresthesia [right]
|
0.00%
0/86 • During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
|
1.2%
1/86 • During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
|
|
Vascular disorders
Hematoma
|
1.2%
1/86 • During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
|
0.00%
0/86 • During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
|
Additional Information
Alicia Kowalski, MD
The University of Texas MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place