Transcutaneous Electrical Acupoint Stimulation of P6 to Prevent Postoperation Nausea and Vomiting
NCT ID: NCT02096835
Last Updated: 2015-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
157 participants
INTERVENTIONAL
2014-01-31
2015-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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
Interventions
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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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* aged between 18 to 60yr
* scheduled for elective gynecological laparoscopic surgery requiring general anesthesia
Exclusion Criteria
* 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
18 Years
60 Years
FEMALE
No
Sponsors
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Huashan Hospital
OTHER
Responsible Party
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Xiao-Yu Yang, MD
MD.
Principal Investigators
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Jun Zhang, MD, PhD
Role: STUDY_CHAIR
Department of Anesthesiology, North Institute of Huashan Hospital,Fudan University
Locations
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Department of Anesthesiology, North Institute of Huashan Hospital,Fudan University
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
Other Identifiers
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TEAS-PONV
Identifier Type: -
Identifier Source: org_study_id
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