Transcutaneous Electrical Acupoint Stimulation (TEAS) of P6 to Prevent Postoperation Nausea and Vomiting (PONV) (TPPP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Huashan Hospital
Sponsor:
Information provided by (Responsible Party):
Xiao-Yu Yang, Huashan Hospital
ClinicalTrials.gov Identifier:
NCT02096835
First received: March 24, 2014
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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 Intervention
Postoperative Nausea and Vomiting
Device: Transcutaneous electrical acupoint stimulation
Device: Sham transcutaneous electrical acupoint stimulation
Drug: Tropisetron
Drug: Dexamethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Transcutaneous Electrical Acupoint P6 Stimulation vs. Tropisetron to Prevent Postoperation Nausea and Vomiting in Gynecological Patients Undergoing Laparoscopic Surgery

Resource links provided by NLM:


Further study details as provided by Huashan Hospital:

Primary Outcome Measures:
  • Incidence of postoperative nausea and vomiting [ Time Frame: within 24h after operation ] [ Designated as safety issue: No ]
    the total incidence including nausea, retching and vomiting


Secondary Outcome Measures:
  • Incidence of postoperative nausea [ Time Frame: 2h, 6h, 24h, 48h after the operation ] [ Designated as safety issue: No ]
  • incidence of postoperative vomiting [ Time Frame: 2h, 6h, 24h, and 48h after operation ] [ Designated as safety issue: No ]
    Including retching and vomiting

  • Number of Participants with Adverse Events [ Time Frame: 2h, 6h, 24h, and 48h after operation ] [ Designated as safety issue: Yes ]
    The number of participants who experience headache, constipation,prolonged QT, swelling or pain in the stimulation site which are probably related with tropisetron or TEAS.


Other Outcome Measures:
  • Dose of postoperative metoclopramide [ Time Frame: within 48h after operation ] [ Designated as safety issue: No ]
  • Dose of postoperative morphine [ Time Frame: within 24h after operaion ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: February 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

130 female patients, aged between 18 to 60 yr, 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02096835

Contacts
Contact: Xiao-Yu Yang, M.D. 086-021-52889999 ext 7693 xiaoyuyangfudan@gmail.com
Contact: Jun Zhang, M.D., Ph.D. 086-021-66895404 snapzhang@aliyun.com

Locations
China, Shanghai
Department of Anesthesiology, North Institute of Huashan Hospital,Fudan University Recruiting
Shanghai, Shanghai, China, 201907
Contact: Zhiming Wang, M.D.    086-021-66895999      
Principal Investigator: Xiao-Yu Yang, MD         
Sub-Investigator: Yan-Hui Chen, College         
Sub-Investigator: Zeng-Tao Wang, MD         
Sub-Investigator: Dong-Hua He, MD         
Sub-Investigator: Jun Xiao, MD         
Sub-Investigator: Lei Wang, MD         
Sponsors and Collaborators
Huashan Hospital
Investigators
Study Chair: Jun Zhang, MD, PhD Department of Anesthesiology, North Institute of Huashan Hospital,Fudan University
  More Information

No publications provided

Responsible Party: Xiao-Yu Yang, MD., Huashan Hospital
ClinicalTrials.gov Identifier: NCT02096835     History of Changes
Other Study ID Numbers: TEAS-PONV
Study First Received: March 24, 2014
Last Updated: April 8, 2014
Health Authority: China: Science and Technology Commission of Shanghai Municipality

Keywords provided by Huashan Hospital:
Postoperative nausea and vomiting
Transcutaneous electrical acupoint stimulation
Gynecological laparoscopic surgery
Tropisetron

Additional relevant MeSH terms:
Vomiting
Postoperative Nausea and Vomiting
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Dexamethasone acetate
Dexamethasone
Tropisetron
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin Antagonists

ClinicalTrials.gov processed this record on August 21, 2014