Transcutaneous Electrical Acupoint Stimulation of P6 to Prevent Postoperation Nausea and Vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

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.
    

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.
    

Intervention name(s): Transcutaneous electrical acupoint stimulation; Sham transcutaneous electrical acupoint stimulation; Tropisetron; Dexamethasone
Intervention type(s): Device; Device; Drug; Drug
Intervention description(s): 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.; 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.; will be given at the start of skin closure; will be given after induction
Other intervention name(s): TEAS; Electrical neuromuscular stimulation device,JNR-2; Tropisetron Hydrocloride Injection; Batch number:131001
Intervention MeSH terms: Dexamethasone; Tropisetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Postoperative nausea and vomiting; Transcutaneous electrical acupoint stimulation; Gynecological laparoscopic surgery; Tropisetron; Dexamethasone