Trial Outcomes & Findings for Transcutaneous Electrical Acupoint Stimulation of P6 to Prevent Postoperation Nausea and Vomiting (NCT NCT02096835)
NCT ID: NCT02096835
Last Updated: 2015-10-12
Results Overview
the total number including nausea, retching and vomiting within 24h after operation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
157 participants
Primary outcome timeframe
within 24h after operation
Results posted on
2015-10-12
Participant Flow
Patients were recruited from Jan 2014 to Dec 2014 in North Institute of Huashan Hospital,Fudan University,Shanghai,China
243 patients were assessed for eligibility, 86 were excluded for reasons below: Refused to participate. (n=12) Did not meet inclusion criteria. (n=71) Insufficient time to prepare for the study. (n=3)
Participant milestones
| Measure |
Acustimulation
Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.
Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.
Dexamethasone: will be given after induction
|
Tropisetron
Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Tropisetron: will be given at the start of skin closure
Dexamethasone: will be given after induction
|
Control
Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Dexamethasone: will be given after induction
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
53
|
51
|
|
Overall Study
COMPLETED
|
50
|
53
|
50
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
1
|
Reasons for withdrawal
| Measure |
Acustimulation
Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.
Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.
Dexamethasone: will be given after induction
|
Tropisetron
Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Tropisetron: will be given at the start of skin closure
Dexamethasone: will be given after induction
|
Control
Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Dexamethasone: will be given after induction
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
converted to open procedures
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
Baseline Characteristics
Transcutaneous Electrical Acupoint Stimulation of P6 to Prevent Postoperation Nausea and Vomiting
Baseline characteristics by cohort
| Measure |
Acustimulation
n=50 Participants
Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.
Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.
Dexamethasone: will be given after induction
|
Tropisetron
n=53 Participants
Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Tropisetron: will be given at the start of skin closure
Dexamethasone: will be given after induction
|
Control
n=50 Participants
Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Dexamethasone: will be given after induction
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37 years
n=5 Participants
|
35 years
n=7 Participants
|
35 years
n=5 Participants
|
35 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
50 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
China
|
50 participants
n=5 Participants
|
53 participants
n=7 Participants
|
50 participants
n=5 Participants
|
153 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: within 24h after operationthe total number including nausea, retching and vomiting within 24h after operation
Outcome measures
| Measure |
Control
n=50 Participants
Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Dexamethasone: will be given after induction
|
Acustimulation
n=50 Participants
Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.
Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.
Dexamethasone: will be given after induction
|
Tropisetron
n=53 Participants
Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Tropisetron: will be given at the start of skin closure
Dexamethasone: will be given after induction
|
|---|---|---|---|
|
Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively
|
25 participants
|
14 participants
|
14 participants
|
SECONDARY outcome
Timeframe: within 24h after the operationOutcome measures
| Measure |
Control
n=50 Participants
Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Dexamethasone: will be given after induction
|
Acustimulation
n=50 Participants
Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.
Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.
Dexamethasone: will be given after induction
|
Tropisetron
n=53 Participants
Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Tropisetron: will be given at the start of skin closure
Dexamethasone: will be given after induction
|
|---|---|---|---|
|
Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively
|
25 participants
|
14 participants
|
14 participants
|
SECONDARY outcome
Timeframe: within 24h after operationincluding retching and vomiting
Outcome measures
| Measure |
Control
n=50 Participants
Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Dexamethasone: will be given after induction
|
Acustimulation
n=50 Participants
Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.
Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.
Dexamethasone: will be given after induction
|
Tropisetron
n=53 Participants
Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Tropisetron: will be given at the start of skin closure
Dexamethasone: will be given after induction
|
|---|---|---|---|
|
Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively
|
12 participants
|
9 participants
|
8 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: within 48h after operationthe number of patients who needed metoclopramide as a rescue medicine postoperatively
Outcome measures
| Measure |
Control
n=50 Participants
Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Dexamethasone: will be given after induction
|
Acustimulation
n=50 Participants
Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.
Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.
Dexamethasone: will be given after induction
|
Tropisetron
n=53 Participants
Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Tropisetron: will be given at the start of skin closure
Dexamethasone: will be given after induction
|
|---|---|---|---|
|
Need of Postoperative Metoclopramide
|
7 participants
|
5 participants
|
4 participants
|
Adverse Events
Acustimulation
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Tropisetron
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acustimulation
n=53 participants at risk
Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.
Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.
Dexamethasone: will be given after induction
|
Tropisetron
n=53 participants at risk
Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Tropisetron: will be given at the start of skin closure
Dexamethasone: will be given after induction
|
Control
n=51 participants at risk
Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.
Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
Dexamethasone: will be given after induction
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Local redness
|
7.5%
4/53 • Number of events 4 • Adverse event data were collected from the start of anesthesia to 48h after the operation.
|
0.00%
0/53 • Adverse event data were collected from the start of anesthesia to 48h after the operation.
|
0.00%
0/51 • Adverse event data were collected from the start of anesthesia to 48h after the operation.
|
|
Skin and subcutaneous tissue disorders
Local itching
|
1.9%
1/53 • Number of events 1 • Adverse event data were collected from the start of anesthesia to 48h after the operation.
|
0.00%
0/53 • Adverse event data were collected from the start of anesthesia to 48h after the operation.
|
0.00%
0/51 • Adverse event data were collected from the start of anesthesia to 48h after the operation.
|
|
Skin and subcutaneous tissue disorders
Local skin swelling
|
1.9%
1/53 • Number of events 1 • Adverse event data were collected from the start of anesthesia to 48h after the operation.
|
0.00%
0/53 • Adverse event data were collected from the start of anesthesia to 48h after the operation.
|
0.00%
0/51 • Adverse event data were collected from the start of anesthesia to 48h after the operation.
|
Additional Information
Dr.Xiaoyu Yang
Huashan Hospital Fudan University Shanghai, China
Phone: 086-021-52889999
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place