AcupunctureTEASNCT02597530
Different Stimuli of Transcutaneous Electric Acupoint Stimulation(TEAS) on Acupuncture Anesthesia
A study testing TEAS in people with Acupuncture, run by wangqiang.
Trial summary
To determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) combined with general anesthetic during peri-operative could alleviate the dosage of anesthetic drugs compared with control and sham group. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acupuncture
- What is being tested?
- TEAS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65
- ASA physical statusⅠorⅡ
- Elective gynecological laparoscopic surgery under general anesthesia
- BMI of 18 to 25
- Duration of operation≤2 hours
- Patient who signed the informed consent
Who cannot join
- Pregnancy or breast-feeding women
- Serious lung disease/Serious cardiovascular disease/Serious liver, renal abnormalities
- Patients who have a history of gastrointestinal surgery or chronic gastrointestinal disease
- Patient has diseases in nervous-mental system
- Operation time more than 2 hours
- Patients with contraindications to the use of electroacupuncture, such as skin damage or infection at the acupoints;
- Patients with experience of transcutaneous electrical stimulation treatment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Different Time of Transcutaneous Electric Acupoint Stimulation(TEAS) on Acupuncture Anesthesia
To determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) combined with general anesthetic during peri-operative could alleviate the dosage of anesthetic drugs compared with control and sham group.
Read the detailed description
Acupuncture is a traditional Chinese medical technique that involves the insertion of needles at acupoints to treat diseases by Jingluo (the system of meridians, through which energy is thought to flow through the body in Chinese medicine). It is usually applied to relieve pain. Several clinical trials have been conducted to evaluate the effect of electroacupuncture on the consumption of intra-operative anaesthetics and on drug-related side-effects, with promising results. Compared with acupuncture or electroacupuncture, transcutaneous electric acupoint stimulation(TEAS) is a non-invasive technique and has some advantages, including no risk of infections or needle-induced contagious disease and reduced fear of stimulation. It can potentially be applied by any anaesthetist or pre-operative personnel with minimal training.Thus, investigators conducted this controlled, prospective, double-blinded clinical trial to investigate whether treating by transcutaneous electrical acupoint stimulation combined with general anesthetic during peri-operative could alleviate the dosage of anesthetic drugs compared with control and sham group.
- Conditions
- Acupuncture
- Being tested
- TEAS
- Keywords
- TEAS, anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEASDevice
According to ancient Chinese medical books, acupoints LI4,PC6 and ST36 are chosen and identified.TEAS in long-term group will be administered 30 minutes prior to anesthesia and continued until the end of the surgery. In short-term group,TEAS will be administered 30 minutes prior to anesthesia and ended at time of anesthesia.In sham group,electrodes will be pasted 30 minutes before anesthesia but without electrical stimulation.All patients will remove electrodes on surgery over.
| Study group | Role | What they receive |
|---|---|---|
| Long-term stimulution group | Experimental | According to ancient Chinese medical books, acupoints Hegu and Zusanli are chosen and identified.Patients in Long-term stimulation group received electrical stimulation with the 'disperse-dense' waves.TEAS will be administered 30 minutes prior to anesthesia and continued until the end of the surgery with dilatational wave(2-15HZ).All patients will remove electrodes on surgery over. Receives: Device: TEAS |
| Short-term stimulution group | Other | According to ancient Chinese medical books, acupoints Hegu and Zusanli are chosen and identified.The patients in Short-term stimulation group received electrical stimulation with the 'disperse-dense' waves.TEAS will be administered 30 minutes prior to anesthesia and ended at time of anesthesia with dilatational wave(2-15HZ).All patients will remove electrodes on surgery over. Receives: Device: TEAS |
| Sham group | Placebo comparator | Patients in sham group will be pasted electrodes 30 minutes before anesthesia but without electrical stimulation.All patients will remove electrodes on surgery over. Receives: Device: TEAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of remifentanil during the operation（ug/kg/min）.
Measured: intraoperative
Secondary outcomes (5)
Content of endocrine hormone in the blood(angiotensin-II(ng/L),Cortisol(nmol/L),β-endorphin(ng/mL) and glucose(mmol/L)).
Measured: intraoperative
Time of extubation after operation.
Measured: intraoperative
Pain after the operation(visual analog scale (vas)).
Measured: 0 hours ,2 hours ,12 hours ,24 hours after operation
Side-effects of anesthetics(nausea,vomiting,dizziness and pruritus).
Measured: 0 hours ,2 hours ,12 hours ,24 hours after operation
Hospital stays after operation(d).
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- wangqiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, wangqiang, Xijing Hospital
- Investigators
- Qiang x Qiang Wang, Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597530
- Sponsor's protocol ID
- Xijingmazui
- Other IDs
- mazuike
- Acronym
- TEAS
- Status last verified
- Dec 2015
- First submitted
- 29 Oct 2015
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang H, Xie Y, Zhang Q, Xu N, Zhong H, Dong H, Liu L, Jiang T, Wang Q, Xiong L. Transcutaneous electric acupoint stimulation reduces intra-operative remifentanil consumption and alleviates postoperative side-effects in patients undergoing sinusotomy: a prospective, randomized, placebo-controlled trial. Br J Anaesth. 2014 Jun;112(6):1075-82. doi: 10.1093/bja/aeu001. Epub 2014 Feb 26.
PubMed 24576720Iacobone M, Citton M, Zanella S, Scarpa M, Pagura G, Tropea S, Galligioni H, Ceccherelli F, Feltracco P, Viel G, Nitti D. The effects of acupuncture after thyroid surgery: A randomized, controlled trial. Surgery. 2014 Dec;156(6):1605-12; discussion 1612-3. doi: 10.1016/j.surg.2014.08.062. Epub 2014 Nov 11.
PubMed 25456960Lee MS, Ernst E. Acupuncture for surgical conditions: an overview of systematic reviews. Int J Clin Pract. 2014 Jun;68(6):783-9. doi: 10.1111/ijcp.12372. Epub 2014 Jan 22.
PubMed 24447388Sahni N, Anand LK, Gombar K, Gombar S. Effect of intraoperative depth of anesthesia on postoperative pain and analgesic requirement: A randomized prospective observer blinded study. J Anaesthesiol Clin Pharmacol. 2011 Oct;27(4):500-5. doi: 10.4103/0970-9185.86595.
PubMed 22096284Han JS. Acupuncture analgesia: areas of consensus and controversy. Pain. 2011 Mar;152(3 Suppl):S41-S48. doi: 10.1016/j.pain.2010.10.012. No abstract available.
PubMed 21078546
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Time of Transcutaneous Electric Acupoint Stimulation(TEAS) on Acupuncture Anesthesia
- ClinicalTrials.gov ID
- NCT02597530
- Acronym / sponsor ID
- TEAS / Xijingmazui
- Conditions
- Acupuncture
- Keywords
- TEAS, anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- wangqiangUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) combined with general anesthetic during peri-operative could alleviate the dosage of anesthetic drugs compared with control and sham group.
Detailed description
Acupuncture is a traditional Chinese medical technique that involves the insertion of needles at acupoints to treat diseases by Jingluo (the system of meridians, through which energy is thought to flow through the body in Chinese medicine). It is usually applied to relieve pain. Several clinical trials have been conducted to evaluate the effect of electroacupuncture on the consumption of intra-operative anaesthetics and on drug-related side-effects, with promising results. Compared with acupuncture or electroacupuncture, transcutaneous electric acupoint stimulation(TEAS) is a non-invasive technique and has some advantages, including no risk of infections or needle-induced contagious disease and reduced fear of stimulation. It can potentially be applied by any anaesthetist or pre-operative personnel with minimal training.Thus, investigators conducted this controlled, prospective, double-blinded clinical trial to investigate whether treating by transcutaneous electrical acupoint stimulation combined with general anesthetic during peri-operative could alleviate the dosage of anesthetic drugs compared with control and sham group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Long-term stimulution group | Experimental | Device: TEASAccording to ancient Chinese medical books, acupoints Hegu and Zusanli are chosen and identified.Patients in Long-term stimulation group received electrical stimulation with the 'disperse-dense' waves.TEAS will be administered 30 minutes prior to anesthesia and continued until the end of the surgery with dilatational wave(2-15HZ).All patients will remove electrodes on surgery over. |
| Short-term stimulution group | Other | Device: TEASAccording to ancient Chinese medical books, acupoints Hegu and Zusanli are chosen and identified.The patients in Short-term stimulation group received electrical stimulation with the 'disperse-dense' waves.TEAS will be administered 30 minutes prior to anesthesia and ended at time of anesthesia with dilatational wave(2-15HZ).All patients will remove electrodes on surgery over. |
| Sham group | Placebo comparator | Device: TEASPatients in sham group will be pasted electrodes 30 minutes before anesthesia but without electrical stimulation.All patients will remove electrodes on surgery over. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 18 and 65
- ASA physical statusⅠorⅡ
- Elective gynecological laparoscopic surgery under general anesthesia
- BMI of 18 to 25
- Duration of operation≤2 hours
Key exclusion criteria (7 listed)
- Pregnancy or breast-feeding women
- Serious lung disease/Serious cardiovascular disease/Serious liver, renal abnormalities
- Patients who have a history of gastrointestinal surgery or chronic gastrointestinal disease
- Patient has diseases in nervous-mental system
- Operation time more than 2 hours
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 |
|---|---|---|
| TEASAccording to ancient Chinese medical books, acupoints LI4,PC6 and ST36 are chosen and identified.TEAS in long-term group will be administered 30 minutes prior to anesthesia and continued until the end of the surgery. In short-term group,TEAS will be administered 30 minutes prior to anesthesia and ended at time of anesthesia.In sham group,electrodes will be pasted 30 minutes before anesthesia but without electrical stimulation.All patients will remove electrodes on surgery over. | Device | Long-term stimulution group, Sham group, Short-term stimulution group |
Primary outcome
Consumption of remifentanil during the operation（ug/kg/min）.
Time frame: intraoperative
5 secondary outcomes
Content of endocrine hormone in the blood(angiotensin-II(ng/L),Cortisol(nmol/L),β-endorphin(ng/mL) and glucose(mmol/L)).
Time frame: intraoperative
Time of extubation after operation.
Time frame: intraoperative
Pain after the operation(visual analog scale (vas)).
Time frame: 0 hours ,2 hours ,12 hours ,24 hours after operation
Side-effects of anesthetics(nausea,vomiting,dizziness and pruritus).
Time frame: 0 hours ,2 hours ,12 hours ,24 hours after operation
Hospital stays after operation(d).
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Background: PubMed 24576720Wang H, Xie Y, Zhang Q, Xu N, Zhong H, Dong H, Liu L, Jiang T, Wang Q, Xiong L. Transcutaneous electric acupoint stimulation reduces intra-operative remifentanil consumption and alleviates postoperative side-effects in patients undergoing sinusotomy: a prospective, randomized, placebo-controlled trial. Br J Anaesth. 2014 Jun;112(6):1075-82. doi: 10.1093/bja/aeu001. Epub 2014 Feb 26.
- Background: PubMed 25456960Iacobone M, Citton M, Zanella S, Scarpa M, Pagura G, Tropea S, Galligioni H, Ceccherelli F, Feltracco P, Viel G, Nitti D. The effects of acupuncture after thyroid surgery: A randomized, controlled trial. Surgery. 2014 Dec;156(6):1605-12; discussion 1612-3. doi: 10.1016/j.surg.2014.08.062. Epub 2014 Nov 11.
- Background: PubMed 24447388Lee MS, Ernst E. Acupuncture for surgical conditions: an overview of systematic reviews. Int J Clin Pract. 2014 Jun;68(6):783-9. doi: 10.1111/ijcp.12372. Epub 2014 Jan 22.
- Background: PubMed 22096284Sahni N, Anand LK, Gombar K, Gombar S. Effect of intraoperative depth of anesthesia on postoperative pain and analgesic requirement: A randomized prospective observer blinded study. J Anaesthesiol Clin Pharmacol. 2011 Oct;27(4):500-5. doi: 10.4103/0970-9185.86595.
- Background: PubMed 21078546Han JS. Acupuncture analgesia: areas of consensus and controversy. Pain. 2011 Mar;152(3 Suppl):S41-S48. doi: 10.1016/j.pain.2010.10.012. No abstract available.
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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.
Qiang x Qiang Wang study chair
Xijing Hospital
Questions about this trial
What is this clinical trial studying?
A study testing TEAS in people with Acupuncture, run by wangqiang.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shan He (15129014406, 986994820@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consumption of remifentanil during the operation（ug/kg/min）. (time frame: intraoperative). 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 NCT02597530, which also lists 5 linked publications.
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 11 Dec 2015.