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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acustimulation | Experimental | 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. |
|
| Tropisetron | Active Comparator | Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction. |
|
| Control | Sham Comparator | Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous electrical acupoint stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively | the total number including nausea, retching and vomiting within 24h after operation | within 24h after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively | within 24h after the operation | |
| Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively | including retching and vomiting |
| Measure | Description | Time Frame |
|---|---|---|
| Need of Postoperative Metoclopramide | the number of patients who needed metoclopramide as a rescue medicine postoperatively | within 48h after operation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Zhang, MD, PhD | Department of Anesthesiology, North Institute of Huashan Hospital,Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, North Institute of Huashan Hospital,Fudan University | Shanghai | Shanghai Municipality | 201907 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26507494 | Derived | Yang XY, Xiao J, Chen YH, Wang ZT, Wang HL, He DH, Zhang J. Dexamethasone alone vs in combination with transcutaneous electrical acupoint stimulation or tropisetron for prevention of postoperative nausea and vomiting in gynaecological patients undergoing laparoscopic surgery. Br J Anaesth. 2015 Dec;115(6):883-9. doi: 10.1093/bja/aev352. Epub 2015 Oct 27. |
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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)
Patients were recruited from Jan 2014 to Dec 2014 in North Institute of Huashan Hospital,Fudan University,Shanghai,China
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Sham transcutaneous electrical acupoint stimulation | Device | 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 | Drug | will be given at the start of skin closure |
|
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| Dexamethasone | Drug | will be given after induction |
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| within 24h after operation |
| FG001 | 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 |
| FG002 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively | the total number including nausea, retching and vomiting within 24h after operation | Posted | Number | participants | within 24h after operation |
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| Secondary | Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively | Posted | Number | participants | within 24h after the operation |
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| Secondary | Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively | including retching and vomiting | Posted | Number | participants | within 24h after operation |
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| Other Pre-specified | Need of Postoperative Metoclopramide | the number of patients who needed metoclopramide as a rescue medicine postoperatively | Posted | Number | participants | within 48h after operation |
|
Adverse event data were collected from the start of anesthesia to 48h after the operation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 53 | 6 | 53 | ||
| EG001 | 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 | 0 | 53 | 0 | 53 | ||
| EG002 | 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 | 0 | 51 | 0 | 51 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Local redness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Local itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Local skin swelling | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Xiaoyu Yang | Huashan Hospital Fudan University Shanghai, China | 086-021-52889999 | 7693 | yangxiaoyu@huashan.org.cn |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
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| ID | Term |
|---|---|
| D000077526 | Tropisetron |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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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
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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
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