AnesthesiaTRIMNCT03912688
TEAS Reduces Remifentanil Consumption
A study testing acupoint stimulation, single acupoint and dual acupoints in people with Anesthesia and Pain, run by Air Force Military Medical University, China.
Trial summary
Transcutaneous electrical acupoint stimulation (TEAS) has been shown to decrease the need of opioids including remifentanil during anaesthesia. However, it is not clear whether combination of two or more acupoints could induce stronger analgesia. Moreover, evidence for the long-term effect of TEAS has been limited. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anesthesia, Pain
- What is being tested?
- acupoint stimulation, single acupoint and dual acupoints
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Dec 2015
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 yrs
- body mass index (BMI) of 18 to 30 kg/m2
- elective radical mastectomy under general anaesthesia
Who cannot join
- contradictions to TEAS
- difficulties in communication
- histories of general anaesthesia
- drug or alcohol abuse or addiction
- cardiac dysfunction or severe hypertension
- confirmed hepatic dysfunction and renal impairment
- the participants recruited into other clinical trials during last three months
About this study
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Remifentanil Consumption and Postoperative Pain in Patients Undergoing Radical Mastectomy
Transcutaneous electrical acupoint stimulation (TEAS) has been shown to decrease the need of opioids including remifentanil during anaesthesia. However, it is not clear whether combination of two or more acupoints could induce stronger analgesia. Moreover, evidence for the long-term effect of TEAS has been limited. The present study was to compare the short-term and long-term effect on pain of dual-acupoint and single-acupoint TEAS.
- Conditions
- Anesthesia, Pain
- Being tested
- acupoint stimulation, single acupoint, dual acupoints
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupoint stimulationDevice
single acupointDevice
dual acupointsDevice
| Study group | Role | What they receive |
|---|---|---|
| single acupoint stimulation | Experimental | Not described Receives: Device: acupoint stimulation; Device: single acupoint |
| dual acupoints stimulation | Experimental | Not described Receives: Device: acupoint stimulation; Device: dual acupoints |
| no stimulation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
consumption of remifentanil
Measured: from start of anesthesia to extubation, on average 2 hours
Secondary outcomes (8)
time to recall
Measured: from end of remifentanil infusion to patient response to verbal command,approximately 10 minutes on average
time to extubation
Measured: from end of remifentanil infusion to extubation,approximately 10 minutes on average
respiratory depression
Measured: end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes
nausea and vomiting
Measured: end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes
visual analogue scale of pain
pain intensity is assessed by a 0-10mm scale, 0 is no pain, 10 is untolerated pain
Measured: end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes
patients' satisfaction score
patients' satisfaction score is assessed by a 0-10mm scale, 0 is no pain, 10 is untolerated pain
Measured: from end of surgery to 24 hours after surgery, totally 24 hours
incidence of pain at 3m after surgery
percentage of patients suffering from pain around the incision
Measured: from discharge from hospital to 3 months after surgery, approximately 3 months
incidence of pain at 6m after surgery
percentage of patients suffering from pain around the incision
Measured: from discharge from hospital to 6 months after surgery, approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study startJul 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong LU, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912688
- Sponsor's protocol ID
- XJA-S-20190212
- Acronym
- TRIM
- Status last verified
- Apr 2019
- First submitted
- 12 Feb 2019
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kuhn LA. Editorial: Acupuncture anesthesia for open heart surgery. Am J Cardiol. 1974 Aug;34(2):254-5. doi: 10.1016/0002-9149(74)90207-0. No abstract available.
PubMed 4843161Lu Z, Dong H, Wang Q, Xiong L. Perioperative acupuncture modulation: more than anaesthesia. Br J Anaesth. 2015 Aug;115(2):183-93. doi: 10.1093/bja/aev227.
PubMed 26170347Wang 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 24576720Yan B, Li K, Xu J, Wang W, Li K, Liu H, Shan B, Tang X. Acupoint-specific fMRI patterns in human brain. Neurosci Lett. 2005 Aug 5;383(3):236-40. doi: 10.1016/j.neulet.2005.04.021.
PubMed 15876491
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Acupoint Stimulation on Remifentanil Consumption and Postoperative Pain in Patients Undergoing Radical Mastectomy
- ClinicalTrials.gov ID
- NCT03912688
- Acronym / sponsor ID
- TRIM / XJA-S-20190212
- Conditions
- Anesthesia, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Apr 2019 (actual)
- 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.
Transcutaneous electrical acupoint stimulation (TEAS) has been shown to decrease the need of opioids including remifentanil during anaesthesia. However, it is not clear whether combination of two or more acupoints could induce stronger analgesia. Moreover, evidence for the long-term effect of TEAS has been limited. The present study was to compare the short-term and long-term effect on pain of dual-acupoint and single-acupoint TEAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| single acupoint stimulation | Experimental | Device: acupoint stimulation, Device: single acupoint |
| dual acupoints stimulation | Experimental | Device: acupoint stimulation, Device: dual acupoints |
| no stimulation | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 65 yrs
- body mass index (BMI) of 18 to 30 kg/m2
- elective radical mastectomy under general anaesthesia
Key exclusion criteria (7 listed)
- contradictions to TEAS
- difficulties in communication
- histories of general anaesthesia
- drug or alcohol abuse or addiction
- cardiac dysfunction or severe hypertension
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 |
|---|---|---|
| acupoint stimulation | Device | dual acupoints stimulation, single acupoint stimulation |
| single acupoint | Device | single acupoint stimulation |
| dual acupoints | Device | dual acupoints stimulation |
Primary outcome
consumption of remifentanil
Time frame: from start of anesthesia to extubation, on average 2 hours
8 secondary outcomes
time to recall
Time frame: from end of remifentanil infusion to patient response to verbal command,approximately 10 minutes on average
time to extubation
Time frame: from end of remifentanil infusion to extubation,approximately 10 minutes on average
respiratory depression
Time frame: end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes
nausea and vomiting
Time frame: end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes
visual analogue scale of pain
Time frame: end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes
patients' satisfaction score
Time frame: from end of surgery to 24 hours after surgery, totally 24 hours
incidence of pain at 3m after surgery
Time frame: from discharge from hospital to 3 months after surgery, approximately 3 months
incidence of pain at 6m after surgery
Time frame: from discharge from hospital to 6 months after surgery, approximately 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Background: PubMed 4843161Kuhn LA. Editorial: Acupuncture anesthesia for open heart surgery. Am J Cardiol. 1974 Aug;34(2):254-5. doi: 10.1016/0002-9149(74)90207-0. No abstract available.
- Results publication: PubMed 26170347Lu Z, Dong H, Wang Q, Xiong L. Perioperative acupuncture modulation: more than anaesthesia. Br J Anaesth. 2015 Aug;115(2):183-93. doi: 10.1093/bja/aev227.
- Results publication: 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.
- Results publication: PubMed 15876491Yan B, Li K, Xu J, Wang W, Li K, Liu H, Shan B, Tang X. Acupoint-specific fMRI patterns in human brain. Neurosci Lett. 2005 Aug 5;383(3):236-40. doi: 10.1016/j.neulet.2005.04.021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing acupoint stimulation, single acupoint and dual acupoints in people with Anesthesia and Pain, run by Air Force Military Medical University, 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 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: finished, as of the sponsor's last update on 11 Apr 2019. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
consumption of remifentanil (time frame: from start of anesthesia to extubation, on average 2 hours). 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 NCT03912688, which also lists 4 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 Apr 2019; AzTrials last refreshed its copy on 31 Oct 2026.