Post-Operative Nausea and Vomiting, Breast Cancer
Conditions
Keywords
Post-operative nausea and vomiting, PONV, Breast cancer, Neuromuscular blockade monitor, NMBM, Breast cancer surgery, Prophylactic anti-emetics, Electrical stimulation, Zofran, Ondansetron, Dexamethasone, Decadron, Phenergan, Promethazine, Phenazine, Phencen, Prometh, Prorex, V-Gan, Pepcid, Famotidine, Questionnaire, Survey
Brief summary
The goal of this clinical research study is to learn if light electrical stimulation to the wrist area during surgery is feasible in women having breast surgery.
Detailed description
Study Groups: If you are eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. If you are in Group 1, you will receive light electrical stimulation to the wrist area during surgery. You will also receive standard of care drugs to reduce PONV. If you have nausea or you are vomiting after surgery, you will receive additional standard of care drugs for those symptoms. You may ask the study staff for information about how the drugs are given and their risks. If you are in Group 2, you will receive standard of care drugs to reduce PONV only (you will not receive electrical stimulation). If you have nausea or you are vomiting after surgery, you will receive additional standard of care drugs for those symptoms. Electrical Stimulation: The electrical stimulation is applied through a small sticky pad that is connected to a machine called a neuromuscular blockade monitor (NMBN). NMBNs are routinely used by anesthesiologists to monitor drug levels in muscles during surgery. The pad will be placed on your wrist after you receive anesthesia and removed at the end of surgery so you will not know what group you are in. Study Procedures: Both Groups: * You will have blood (about 2 teaspoons) collected intravenously (through your IV) during surgery. This blood will be used for genetic testing that may explain why people respond differently to treatments for nausea and vomiting. * You will complete a questionnaire about your pre-treatment expectations and your nausea every 15 minutes after you wake up after surgery until you leave the clinic. It should take about 2-3 minutes to complete the questionnaire each time. Length of Study: Your participation in this study will be over once you leave the clinic after surgery. This is an investigational study. The NMBM monitor is commercially available and FDA approved for use by anesthesiologists to monitor drug levels in the muscles during surgery. Its use in this study to control nausea/vomiting is investigational. Up to 176 participants will be enrolled in this study. All will be enrolled at MD Anderson.
Interventions
PROCEDUREElectrical Stimulation
Electrical stimulation to the wrist initiated at 1mHz, 1 pulse/second using two leads on a nerve stimulator. Stimulation continued throughout the breast surgery.
DRUGZofran
4 mg by vein for 1 dose.
DRUGDexamethasone
10 mg by vein for 1 dose.
DRUGPhenergan
6.25 mg by vein for 1 dose.
DRUGPepcid
10 mg by vein for 1 dose.
BEHAVIORALQuestionnaire
Questionnaire completed about 15 minutes after participant wakes up after surgery, then every 30 minutes until they leave the clinic. It should take about 2 - 3 minutes to complete the questionnaire.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults at least 18 years of age 2. Female gender 3. History of patient reported PONV, CINV or motion sickness 4. Patients scheduled for Breast Surgery 5. Sign an informed consent indicating they are aware of the investigational nature of this study.
Exclusion criteria
1. Patients scheduled for paravertebral block 2. Upper extremity deformity contralateral to the site of disease that could interfere with accurate point location or alter the energy pathway as defined by traditional acupuncture theory 3. Local skin infections at or near the acustimulation site 4. Pre-existing nausea and vomiting, defined as nausea or vomiting requiring pharmacological treatment greater than 3 times in the week preceding screening 5. History of CVA or other central nervous system disorder resulting in residual weakness or paresis of extremity contralateral to the site of disease 6. Grade III or IV upper extremity peripheral neuropathy 7. Cardiac pacemakers. Patients involved in this protocol will receive electrical stimulation. For safety reasons, electrical stimulation should be avoided in patients with pacemakers 8. Metal implants for the treatment extremity. For safety reasons, use of electrical stimulation should be avoided 9. Current acknowledged use of any illicit drugs, medical marijuana (including Marinol), or evidence of alcohol abuse as defined by The American Psychiatric Association criteria. This includes patients who are currently in the recovery process. 10. Pregnancy as this would alter anesthesia plan 11. Bowel obstruction 12. Surgery that would not allow access to at least one P6 site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Conducting Study | At 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 |
| Efficacy of Intervention to Prevent Need for Rescue Anti-emetics | During stay in post-operative anesthesia care unit, until discharge, an average of 1 day | Examine the effects of intra-operative NMBM stimulation of P6 on whether or not any anti-emetics were used compared to the control group |
| Satisfaction | At 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. |
| Efficacy of Intervention to Result in Decreased PACU Length-of-stay | During stay in post-operative anesthesia care unit, until discharge, an average of 1 day | Explore if intra-operative NMBM stimulation of P6 results in decreased PACU length-of-stay |
| Expectancy | Baseline | 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. |
| Expectancy and Response to P6 Stimulation | During 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Anesthesiologist-provided intraoperative electrical stimulation of P6 with a neuromuscular blockade monitor, combined with prophylactic anti-emetics | 86 |
| Control Only prophylactic anti-emetics | 86 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | PACU data unable to be collected | 3 | 0 |
| Overall Study | Patient became ineligible after enrollment | 2 | 5 |
| Overall Study | Surgery started before study preparation could be completed | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 57.41 years STANDARD_DEVIATION 10.32 | 58.35 years STANDARD_DEVIATION 11.71 | 57.88 years STANDARD_DEVIATION 11.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 13 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 69 Participants | 71 Participants | 140 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 9 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 8 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 71 Participants | 64 Participants | 135 Participants |
| Region of Enrollment United States | 86 participants | 86 participants | 172 participants |
| Sex: Female, Male Female | 86 Participants | 86 Participants | 172 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 0 / 86 |
| other Total, other adverse events | 4 / 86 | 11 / 86 |
| serious Total, serious adverse events | 0 / 86 | 0 / 86 |
Outcome results
Primary
Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV)
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
Time frame: During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV) | Fail | 19 Participants |
| Intervention | Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV) | Success | 67 Participants |
| Intervention | Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV) | Missing Information | 0 Participants |
| Control | Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV) | Fail | 12 Participants |
| Control | Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV) | Success | 71 Participants |
| Control | Efficacy of Intervention to Prevent Post-Operative Nausea and Vomiting (PONV) | Missing Information | 3 Participants |
p-value: 0.2787Chi-squared
Secondary
Efficacy of Intervention to Prevent Need for Rescue Anti-emetics
Examine the effects of intra-operative NMBM stimulation of P6 on whether or not any anti-emetics were used compared to the control group
Time frame: During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
Population: Number of participants analyzed does not match number of participants who completed in participant flow due to missing data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Efficacy of Intervention to Prevent Need for Rescue Anti-emetics | 3 | 1 Participants |
| Intervention | Efficacy of Intervention to Prevent Need for Rescue Anti-emetics | No | 45 Participants |
| Intervention | Efficacy of Intervention to Prevent Need for Rescue Anti-emetics | Yes | 14 Participants |
| Intervention | Efficacy of Intervention to Prevent Need for Rescue Anti-emetics | 0 | 45 Participants |
| Intervention | Efficacy of Intervention to Prevent Need for Rescue Anti-emetics | 1 | 6 Participants |
| Intervention | Efficacy of Intervention to Prevent Need for Rescue Anti-emetics | 2 | 7 Participants |
| Control | Efficacy of Intervention to Prevent Need for Rescue Anti-emetics | 1 | 10 Participants |
| Control | Efficacy of Intervention to Prevent Need for Rescue Anti-emetics | 3 | 0 Participants |
| Control | Efficacy of Intervention to Prevent Need for Rescue Anti-emetics | 0 | 54 Participants |
| Control | Efficacy of Intervention to Prevent Need for Rescue Anti-emetics | No | 54 Participants |
| Control | Efficacy of Intervention to Prevent Need for Rescue Anti-emetics | 2 | 1 Participants |
| Control | Efficacy of Intervention to Prevent Need for Rescue Anti-emetics | Yes | 11 Participants |
Secondary
Efficacy of Intervention to Result in Decreased PACU Length-of-stay
Explore if intra-operative NMBM stimulation of P6 results in decreased PACU length-of-stay
Time frame: During stay in post-operative anesthesia care unit, until discharge, an average of 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Efficacy of Intervention to Result in Decreased PACU Length-of-stay | 120 number of minutes | Standard Deviation 53.07 |
| Control | Efficacy of Intervention to Result in Decreased PACU Length-of-stay | 119.46 number of minutes | Standard Deviation 49.88 |
p-value: 0.8277Wilcoxon (Mann-Whitney)
Secondary
Expectancy
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.
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Expectancy | Response to ASES_Coping question: Not at all Agree/A little Agree | 13 Participants |
| Intervention | Expectancy | Response to ASES_Coping question: Moderately Agree | 14 Participants |
| Intervention | Expectancy | Response to ASES_Coping question: Mostly Agree/Completely Agree | 45 Participants |
| Intervention | Expectancy | Response to ASES_Coping question: Missing | 14 Participants |
| Intervention | Expectancy | Response to ASES_Nausea question: Not at all Agree/A little Agree | 11 Participants |
| Intervention | Expectancy | Response to ASES_Nausea question: Moderately Agree | 18 Participants |
| Intervention | Expectancy | Response to ASES_Nausea question: Mostly Agree/Completely Agree | 43 Participants |
| Intervention | Expectancy | Response to ASES_Nausea question: Missing | 14 Participants |
| Intervention | Expectancy | Response to ASES_Pain question: Not at all Agree/A little Agree | 17 Participants |
| Intervention | Expectancy | Response to ASES_Pain question: Moderately Agree | 18 Participants |
| Intervention | Expectancy | Response to ASES_Pain question: Mostly Agree/Completely Agree | 37 Participants |
| Intervention | Expectancy | Response to ASES_Pain question: Missing | 14 Participants |
| Intervention | Expectancy | Response to ASES_Recovery question: Not at all Agree/A little Agree | 14 Participants |
| Intervention | Expectancy | Response to ASES_Recovery question: Moderately Agree | 13 Participants |
| Intervention | Expectancy | Response to ASES_Recovery question: Mostly Agree/Completely Agree | 45 Participants |
| Intervention | Expectancy | Response to ASES_Recovery question: Missing | 14 Participants |
| Control | Expectancy | Response to ASES_Recovery question: Missing | 23 Participants |
| Control | Expectancy | Response to ASES_Coping question: Not at all Agree/A little Agree | 8 Participants |
| Control | Expectancy | Response to ASES_Pain question: Not at all Agree/A little Agree | 17 Participants |
| Control | Expectancy | Response to ASES_Coping question: Moderately Agree | 18 Participants |
| Control | Expectancy | Response to ASES_Recovery question: Not at all Agree/A little Agree | 10 Participants |
| Control | Expectancy | Response to ASES_Coping question: Mostly Agree/Completely Agree | 37 Participants |
| Control | Expectancy | Response to ASES_Pain question: Moderately Agree | 18 Participants |
| Control | Expectancy | Response to ASES_Coping question: Missing | 23 Participants |
| Control | Expectancy | Response to ASES_Recovery question: Mostly Agree/Completely Agree | 42 Participants |
| Control | Expectancy | Response to ASES_Nausea question: Not at all Agree/A little Agree | 6 Participants |
| Control | Expectancy | Response to ASES_Pain question: Mostly Agree/Completely Agree | 29 Participants |
| Control | Expectancy | Response to ASES_Nausea question: Moderately Agree | 17 Participants |
| Control | Expectancy | Response to ASES_Recovery question: Moderately Agree | 12 Participants |
| Control | Expectancy | Response to ASES_Nausea question: Mostly Agree/Completely Agree | 40 Participants |
| Control | Expectancy | Response to ASES_Pain question: Missing | 23 Participants |
| Control | Expectancy | Response to ASES_Nausea question: Missing | 23 Participants |
Comparison: Response to ASES\_Coping question (Re-categorized)p-value: 0.3908Chi-squared
Comparison: Response to ASES\_Nausea questionp-value: 0.6029Chi-squared
Comparison: Response to ASES\_Pain questionp-value: 0.7785Chi-squared
Comparison: Response to ASES\_Recovery question (Re-categorized)p-value: 0.8434Chi-squared
Secondary
Expectancy and Response to P6 Stimulation
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.
Time frame: During stay in post-operative anesthesia care unit, until discharge
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Expectancy and Response to P6 Stimulation | Response to ASES_Coping question: Not at all Agree/A little Agree | 6 Participants |
| Intervention | Expectancy and Response to P6 Stimulation | Response to ASES_Pain question: Not at all Agree/A little Agree | 7 Participants |
| Intervention | Expectancy and Response to P6 Stimulation | Response to ASES_Nausea question: Not at all Agree/A little Agree | 5 Participants |
| Intervention | Expectancy and Response to P6 Stimulation | Response to ASES_Pain question: Moderately Agree | 5 Participants |
| Intervention | Expectancy and Response to P6 Stimulation | Response to ASES_Coping question: Mostly Agree/Completely Agree | 9 Participants |
| Intervention | Expectancy and Response to P6 Stimulation | Response to ASES_Pain question: Mostly Agree/Completely Agree | 9 Participants |
| Intervention | Expectancy and Response to P6 Stimulation | Response to ASES_Nausea question: Moderately Agree | 7 Participants |
| Intervention | Expectancy and Response to P6 Stimulation | Response to ASES_Pain question: Missing | 10 Participants |
| Intervention | Expectancy and Response to P6 Stimulation | Response to ASES_Coping question: Moderately Agree | 6 Participants |
| Intervention | Expectancy and Response to P6 Stimulation | Response to ASES_Recovery question: Not at all Agree/A little Agree | 7 Participants |
| Intervention | Expectancy and Response to P6 Stimulation | Response to ASES_Nausea question: Mostly Agree/Completely Agree | 9 Participants |
| Intervention | Expectancy and Response to P6 Stimulation | Response to ASES_Coping question: Missing | 10 Participants |
| Intervention | Expectancy and Response to P6 Stimulation | Response to ASES_Recovery question: Mostly Agree/Completely Agree | 10 Participants |
| Intervention | Expectancy and Response to P6 Stimulation | Response to ASES_Nausea question: Missing | 10 Participants |
| Intervention | Expectancy and Response to P6 Stimulation | Response to ASES_Recovery question: Missing | 10 Participants |
| Intervention | Expectancy and Response to P6 Stimulation | Response to ASES_Recovery question: Moderately Agree | 4 Participants |
| Control | Expectancy and Response to P6 Stimulation | Response to ASES_Recovery question: Missing | 25 Participants |
| Control | Expectancy and Response to P6 Stimulation | Response to ASES_Coping question: Not at all Agree/A little Agree | 15 Participants |
| Control | Expectancy and Response to P6 Stimulation | Response to ASES_Coping question: Moderately Agree | 25 Participants |
| Control | Expectancy and Response to P6 Stimulation | Response to ASES_Coping question: Mostly Agree/Completely Agree | 72 Participants |
| Control | Expectancy and Response to P6 Stimulation | Response to ASES_Coping question: Missing | 26 Participants |
| Control | Expectancy and Response to P6 Stimulation | Response to ASES_Nausea question: Not at all Agree/A little Agree | 12 Participants |
| Control | Expectancy and Response to P6 Stimulation | Response to ASES_Nausea question: Moderately Agree | 27 Participants |
| Control | Expectancy and Response to P6 Stimulation | Response to ASES_Nausea question: Mostly Agree/Completely Agree | 73 Participants |
| Control | Expectancy and Response to P6 Stimulation | Response to ASES_Nausea question: Missing | 26 Participants |
| Control | Expectancy and Response to P6 Stimulation | Response to ASES_Pain question: Not at all Agree/A little Agree | 27 Participants |
| Control | Expectancy and Response to P6 Stimulation | Response to ASES_Pain question: Moderately Agree | 30 Participants |
| Control | Expectancy and Response to P6 Stimulation | Response to ASES_Pain question: Mostly Agree/Completely Agree | 56 Participants |
| Control | Expectancy and Response to P6 Stimulation | Response to ASES_Pain question: Missing | 25 Participants |
| Control | Expectancy and Response to P6 Stimulation | Response to ASES_Recovery question: Not at all Agree/A little Agree | 17 Participants |
| Control | Expectancy and Response to P6 Stimulation | Response to ASES_Recovery question: Moderately Agree | 20 Participants |
| Control | Expectancy and Response to P6 Stimulation | Response to ASES_Recovery question: Mostly Agree/Completely Agree | 76 Participants |
Comparison: Response to ASES\_Coping question (Re-categorized) and P6 stimulation outcomep-value: 0.2742Chi-squared
Comparison: Response to ASES\_Nausea question (Re-categorized) and P6 stimulation outcomep-value: 0.2747Chi-squared
Comparison: Response to ASES\_Pain question (Re-categorized) and P6 stimulation outcomep-value: 0.5608Chi-squared
Comparison: Response to ASES\_Recovery question (Re-categorized) and P6 stimulation outcomep-value: 0.1014Chi-squared
Secondary
Feasibility of Conducting Study
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
Time frame: At study consent and at PACU discharge
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Feasibility of Conducting Study | Screened eligible | 233 Participants |
| Intervention | Feasibility of Conducting Study | Consented | 188 Participants |
| Intervention | Feasibility of Conducting Study | Completed study | 86 Participants |
Secondary
Satisfaction
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.
Time frame: At discharge from post-operative anesthesia care unit
Population: Number of participants analyzed does not match number of participants who completed in participant flow due to missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Satisfaction | 8.92 Satisfaction score | Standard Deviation 2.51 |
| Control | Satisfaction | 9.25 Satisfaction score | Standard Deviation 1.79 |
p-value: 0.8252Wilcoxon (Mann-Whitney)