Postoperative Nausea and VomitingTEASP6PPONVNCT02096835
Transcutaneous Electrical Acupoint Stimulation of P6 to Prevent Postoperation Nausea and Vomiting
A study testing Transcutaneous electrical acupoint stimulation, Tropisetron and Dexamethasone in people with Postoperative Nausea and Vomiting, run by Huashan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Transcutaneous electrical acupoint stimulation, Tropisetron and Dexamethasone
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I or II
- aged between 18 to 60yr
- scheduled for elective gynecological laparoscopic surgery requiring general anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, North Institute of Huashan Hospital,Fudan University
Shanghai, Shanghai Municipality, 201907
About this study
Official title: Transcutaneous Electrical Acupoint P6 Stimulation vs. Tropisetron Both in Combination With Dexamethasone to Prevent Postoperation Nausea and Vomiting in Women
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.
Read the 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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Transcutaneous electrical acupoint stimulation, Sham transcutaneous electrical acupoint stimulation, Tropisetron, Dexamethasone
- Keywords
- Postoperative nausea and vomiting, Transcutaneous electrical acupoint stimulation, Gynecological laparoscopic surgery, Tropisetron, Dexamethasone
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical acupoint stimulationDevice
Also called TEAS, Electrical neuromuscular stimulation device,JNR-2
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 stimulationDevice
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.
TropisetronDrug
Also called Tropisetron Hydrocloride Injection, Batch number:131001
will be given at the start of skin closure
DexamethasoneDrug
will be given after induction
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcutaneous electrical acupoint stimulation; Drug: Dexamethasone |
| Tropisetron | Active comparator | Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction. Receives: Device: Sham transcutaneous electrical acupoint stimulation; Drug: Tropisetron; Drug: Dexamethasone |
| Control | Sham comparator | Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction. Receives: Device: Sham transcutaneous electrical acupoint stimulation; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively
the total number including nausea, retching and vomiting within 24h after operation
Measured: within 24h after operation
Secondary outcomes (2)
Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively
Measured: within 24h after the operation
Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively
including retching and vomiting
Measured: within 24h after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Yu Yang, MD, Huashan Hospital
- Investigators
- Jun Zhang, MD, PhD, Study chair, Department of Anesthesiology, North Institute of Huashan Hospital,Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096835
- Sponsor's protocol ID
- TEAS-PONV
- Acronym
- TEASP6PPONV
- Status last verified
- Oct 2015
- First submitted
- 24 Mar 2014
- Last updated
- 12 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 26507494
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Acupoint P6 Stimulation vs. Tropisetron Both in Combination With Dexamethasone to Prevent Postoperation Nausea and Vomiting in Women
- ClinicalTrials.gov ID
- NCT02096835
- Acronym / sponsor ID
- TEASP6PPONV / TEAS-PONV
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Postoperative nausea and vomiting, Transcutaneous electrical acupoint stimulation, Gynecological laparoscopic surgery, Tropisetron, Dexamethasone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Posted 10 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acustimulation | Experimental | Device: Transcutaneous electrical acupoint stimulation, Drug: DexamethasoneTranscutaneous 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 | Device: Sham transcutaneous electrical acupoint stimulation, Drug: Tropisetron, Drug: DexamethasoneTropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction. |
| Control | Sham comparator | Device: Sham transcutaneous electrical acupoint stimulation, Drug: DexamethasoneSham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status I or II
- aged between 18 to 60yr
- scheduled for elective gynecological laparoscopic surgery requiring general anesthesia
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical acupoint stimulationAlso: TEAS, Electrical neuromuscular stimulation device,JNR-2A 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. | Device | Acustimulation |
| Sham transcutaneous electrical acupoint stimulationThe 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. | Device | Control, Tropisetron |
| TropisetronAlso: Tropisetron Hydrocloride Injection, Batch number:131001will be given at the start of skin closure | Drug | Tropisetron |
| Dexamethasonewill be given after induction | Drug | Acustimulation, Control, Tropisetron |
Primary outcome
Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively
Time frame: within 24h after operation
the total number including nausea, retching and vomiting within 24h after operation
2 secondary outcomes
Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively
Time frame: within 24h after the operation
Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively
Time frame: within 24h after operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26507494Yang 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Zhang, MD, PhD study chair
Department of Anesthesiology, North Institute of Huashan Hospital,Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical acupoint stimulation, Tropisetron and Dexamethasone in people with Postoperative Nausea and Vomiting, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively (time frame: within 24h after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02096835, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.