TEASP6PPONV: Transcutaneous Electrical Acupoint Stimulation of P6 to Prevent Postoperation Nausea and Vomiting

• Sponsor: Huashan Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02096835
• Collaborator: (none)
• Enrollment: 157
• Location: 1
• Arms: 3
• Duration (Months): 12
• Patients Per Site Per Month: 13.1

Study Details

Study Description

Brief Summary

The purpose of this study is to access the effect of TEAS of P6 in the prevention of PONV in women scheduled for gynecologic laparoscopic surgery with general anesthesia.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting	Device: Transcutaneous electrical acupoint stimulation; Device: Sham transcutaneous electrical acupoint stimulation; Drug: Tropisetron; Drug: Dexamethasone	N/A

Detailed Description

150 female patients, aged between 18 to 60 y, who are scheduled for elective gynecological laparoscopic surgery requiring general anesthesia, will be randomly allocated by a computer generated randomization table to acustimulation group (Group Acu), tropisetron group (Group Trp),or dexamethasone group (Group Dxm).

In Group Acu, a surface electrode will be applied in the induction room to the P6 acupoint 30 min before induction.An operator will set electric stimulating current at 1mA with frequency at 2 Hz, and gradually increased the current intensity to a little below discomfort threshold.The stimulation will be maintained until the patient is discharged from the post-anesthesia care unit (PACU). In Group Trp and Group Dxm, the same protocol will be applied unless silicone covers attached to both electrodes.

A standardized anesthetic protocol will be followed. After induction, dexamethasone 10mg i.v. will be given in all groups. All patients will receive intravenous lactated Ringer's solution based on calculated preoperative deficits, surgical procedure, and estimated intraoperative blood loss. Parecoxib 40mg i.v. during surgery and incision infiltration of 0.5% ropivacaine at the end of surgery will be used for post-operative analgesia. After surgery, analgetic therapy will continue with morphine upon patient's request.After extubation, patients will be transported to PACU and observed for no less than 30 min. Metoclopramide 10mg i.v. will be administered as a rescue therapy to any patient who experiences an episode of moderate or severe nausea, an episode of vomiting, and requests rescue medication.

At the start of skin closure, a prefilled syringe which contains 5 ml of a solution will be administered intravenously to the patient. It will contain either saline (Group Acu and Group Dxm) or tropisetron 5mg (Group Trp).The syringe with the drug will be prepared by a study coordinator according to group allocation.

The patients, the anesthesiologists, and the nursing staff shall be unaware of the group assignments.

An anesthesiologist and an anesthetic nurse, who are trained for the study and blinded to the randomization, will collect the data.

Study Design

• Study Type: Interventional
• Actual Enrollment: 157 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Transcutaneous Electrical Acupoint P6 Stimulation vs. Tropisetron Both in Combination With Dexamethasone to Prevent Postoperation Nausea and Vomiting in Women
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.; Other Names: TEAS Electrical neuromuscular stimulation device,JNR-2 ; Drug: Dexamethasone; will be given after induction
Active Comparator: Tropisetron Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.	Device: 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.; Drug: Tropisetron; will be given at the start of skin closure; Other Names: Tropisetron Hydrocloride Injection Batch number:131001 ; Drug: Dexamethasone; will be given after induction
Sham Comparator: Control Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.	Device: 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.; Drug: Dexamethasone; will be given after induction

Outcome Measures

Primary Outcome Measures

1. Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively [within 24h after operation]

   the total number including nausea, retching and vomiting within 24h after operation

Secondary Outcome Measures

1. Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively [within 24h after the operation]

2. Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively [within 24h after operation]

   including retching and vomiting

Other Outcome Measures

1. Need of Postoperative Metoclopramide [within 48h after operation]

   the number of patients who needed metoclopramide as a rescue medicine postoperatively

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status I or II

• aged between 18 to 60yr

• scheduled for elective gynecological laparoscopic surgery requiring general anesthesia

Exclusion Criteria:

• pregnancy or breastfeeding

• mental retardation

• psychiatric or neurological disease

• use of antiemetics, emetogenic drugs, opioids or glucocorticosteroids within 3 days prior to surgery

• known allergy to tropisetron or dexamethasone

• nausea and/or vomiting within 24 hr prior to surgery

• implantation of a cardiac pacemaker, cardioverter, or defibrillator

• any skin problem at the acupoint stimulation area

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology, North Institute of Huashan Hospital,Fudan University	Shanghai	Shanghai	China	201907

Sponsors and Collaborators

• Huashan Hospital

Investigators

• Study Chair: Jun Zhang, MD, PhD, Department of Anesthesiology, North Institute of Huashan Hospital,Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiao-Yu Yang, MD, MD., Huashan Hospital
• ClinicalTrials.gov Identifier: NCT02096835
• Other Study ID Numbers: TEAS-PONV
• First Posted: Mar 26, 2014
• Last Update Posted: Oct 12, 2015
• Last Verified: Oct 1, 2015

• Keywords provided by Xiao-Yu Yang, MD, MD., Huashan Hospital: Postoperative nausea and vomiting; Transcutaneous electrical acupoint stimulation; Gynecological laparoscopic surgery; Tropisetron; Dexamethasone
• Additional relevant MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting; Dexamethasone; Tropisetron

Study Results

Participant Flow

Recruitment Details	Patients were recruited from Jan 2014 to Dec 2014 in North Institute of Huashan Hospital,Fudan University,Shanghai,China
Pre-assignment Detail	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)

Arm/Group Title	Acustimulation	Tropisetron	Control
Arm/Group Description	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 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	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
Period Title: Overall Study
STARTED	53	53	51
COMPLETED	50	53	50
NOT COMPLETED	3	0	1

Baseline Characteristics

Arm/Group Title	Acustimulation	Tropisetron	Control	Total
Arm/Group Description	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 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	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 of all reporting groups
Overall Participants	50	53	50	153
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	37	35	35	35
Sex: Female, Male (Count of Participants)
Female	50 100%	53 100%	50 100%	153 100%
Male	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	50 100%	53 100%	50 100%	153 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
China	50 100%	53 100%	50 100%	153 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively
Description	the total number including nausea, retching and vomiting within 24h after operation
Time Frame	within 24h after operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acustimulation	Tropisetron	Control
Arm/Group Description	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 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	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
Measure Participants	50	53	50
Number [participants]	14 28%	14 26.4%	25 50%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acustimulation, Tropisetron, Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.021
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively
Time Frame	within 24h after the operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acustimulation	Tropisetron	Control
Arm/Group Description	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 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	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
Measure Participants	50	53	50
Number [participants]	14 28%	14 26.4%	25 50%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acustimulation, Tropisetron, Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.021
	Comments
	Method	Chi-squared
	Comments

3. Secondary Outcome

Title	Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively
Description	including retching and vomiting
Time Frame	within 24h after operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acustimulation	Tropisetron	Control
Arm/Group Description	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 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	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
Measure Participants	50	53	50
Number [participants]	9 18%	8 15.1%	12 24%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acustimulation, Tropisetron, Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.503
	Comments
	Method	Chi-squared
	Comments

4. Other Pre-specified Outcome

Title	Need of Postoperative Metoclopramide
Description	the number of patients who needed metoclopramide as a rescue medicine postoperatively
Time Frame	within 48h after operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acustimulation	Tropisetron	Control
Arm/Group Description	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 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	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
Measure Participants	50	53	50
Number [participants]	5 10%	4 7.5%	7 14%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acustimulation, Tropisetron, Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.571
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	Adverse event data were collected from the start of anesthesia to 48h after the operation.
Arm/Group Title	Acustimulation		Tropisetron		Control
Arm/Group Description	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 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		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
All Cause Mortality
	Acustimulation		Tropisetron		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Acustimulation		Tropisetron		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/53 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	Acustimulation		Tropisetron		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/53 (11.3%)		0/53 (0%)		0/51 (0%)
Skin and subcutaneous tissue disorders
Local redness	4/53 (7.5%)	4	0/53 (0%)	0	0/51 (0%)	0
Local itching	1/53 (1.9%)	1	0/53 (0%)	0	0/51 (0%)	0
Local skin swelling	1/53 (1.9%)	1	0/53 (0%)	0	0/51 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.