HypotensionNCT02611388
Neurohumoral Mechanism of Deferent Frequency Transcutaneous Electrical Acupoint Stimulation(TEAS)
A study testing TEAS (transcutaneous electrical acupoint stimulation) and fake stimulation in people with Hypotension, run by wangqiang.
Trial summary
The purpose of this study is to explore the neurohumoral mechanism of deferent frequency TEAS pretreatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypotension
- What is being tested?
- TEAS (transcutaneous electrical acupoint stimulation) and fake stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Jun 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18yrs-65yrs
- ASA 1-2
- Scheduled for elective operation under general anesthesia
- BMI 18-30kg/m2
- Informed consented
Who cannot join
- Contraindications to TEAS
- Communication difficulty with researchers
- Addicted to alcohol, analgesics or other drugs
- Cardiac insufficiency or high blood pressure without controlled
- Hepatic or renal dysfunction
- Participate in the other clinical trial 3 month before the enrollment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Neurohumor Mechanism of Deferent Frequency Transcutaneous Electrical Acupoint Stimulation(TEAS): A Prospective, Randomized Controlled Trial
The purpose of this study is to explore the neurohumoral mechanism of deferent frequency TEAS pretreatment.
Read the detailed description
Patients were randomly assigned to three groups, receiving TEAS 30min before anesthesia. The frequency of high frequency group is set to 10/50HZ, low frequency group is 2/10HZ, and the fake stimulation group only attach electrodes without electric current. Acupoint selection is bilateral Neiguan points(PC6). Venous blood is collected 4ml before and immediately after TEAS respectively. Heart rate variability is monitored continuously during the 30min TEAS. The adverse events recorded.
- Conditions
- Hypotension
- Being tested
- TEAS (transcutaneous electrical acupoint stimulation), fake stimulation
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEAS (transcutaneous electrical acupoint stimulation)Device
2/10HZ Electric stimulation was given through electrode attached to specific acupoints
TEAS (transcutaneous electrical acupoint stimulation)Device
10/50HZ Electric stimulation was given through electrode attached to specific acupoints
fake stimulationDevice
Patients were only attached electrodes without electric current
| Study group | Role | What they receive |
|---|---|---|
| 2/10HZ TEAS pretreatment | Experimental | Patients were given 30min of 2/10HZ TEAS before anesthesia Receives: Device: TEAS (transcutaneous electrical acupoint stimulation) |
| 10/50HZ TEAS pretreatment | Experimental | Patients were given 30min of 10/50HZ TEAS before anesthesia Receives: Device: TEAS (transcutaneous electrical acupoint stimulation) |
| fake stimulation | Sham comparator | Patients were only attached electrodes without electric current Receives: Device: fake stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of epinephrine(ng/L)
Measured: change of TEAS 0 and 30 minutes
Plasma concentration of norepinephrine(ng/L)
Measured: change of TEAS 0 and 30 minutes
Secondary outcomes (5)
Heart rate variability
Measured: During 30min TEAS
plasma concentration of glucocorticoid(μg/L)
Measured: change of TEAS 0 and 30 minutes
plasma concentration of aldosterone(ng/L)
Measured: change of TEAS 0 and 30 minutes
plasma concentration of renin(ng/L)
Measured: change of TEAS 0 and 30 minutes
plasma concentration of β-endorphin(ng/L)
Measured: change of TEAS 0 and 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionApr 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- wangqiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, wangqiang, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611388
- Sponsor's protocol ID
- XJH-A-2015-10-28
- Status last verified
- Nov 2015
- First submitted
- 15 Nov 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lu 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 26170347
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurohumor Mechanism of Deferent Frequency Transcutaneous Electrical Acupoint Stimulation(TEAS): A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02611388
- Acronym / sponsor ID
- XJH-A-2015-10-28
- Conditions
- Hypotension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- wangqiangUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 20 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.
The purpose of this study is to explore the neurohumoral mechanism of deferent frequency TEAS pretreatment.
Detailed description
Patients were randomly assigned to three groups, receiving TEAS 30min before anesthesia. The frequency of high frequency group is set to 10/50HZ, low frequency group is 2/10HZ, and the fake stimulation group only attach electrodes without electric current. Acupoint selection is bilateral Neiguan points(PC6). Venous blood is collected 4ml before and immediately after TEAS respectively. Heart rate variability is monitored continuously during the 30min TEAS. The adverse events recorded.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2/10HZ TEAS pretreatment | Experimental | Device: TEAS (transcutaneous electrical acupoint stimulation)Patients were given 30min of 2/10HZ TEAS before anesthesia |
| 10/50HZ TEAS pretreatment | Experimental | Device: TEAS (transcutaneous electrical acupoint stimulation)Patients were given 30min of 10/50HZ TEAS before anesthesia |
| fake stimulation | Sham comparator | Device: fake stimulationPatients were only attached electrodes without electric current |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18yrs-65yrs
- ASA 1-2
- Scheduled for elective operation under general anesthesia
- BMI 18-30kg/m2
- Informed consented
Key exclusion criteria (6 listed)
- Contraindications to TEAS
- Communication difficulty with researchers
- Addicted to alcohol, analgesics or other drugs
- Cardiac insufficiency or high blood pressure without controlled
- Hepatic or renal dysfunction
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 |
|---|---|---|
| TEAS (transcutaneous electrical acupoint stimulation)2/10HZ Electric stimulation was given through electrode attached to specific acupoints | Device | 2/10HZ TEAS pretreatment |
| TEAS (transcutaneous electrical acupoint stimulation)10/50HZ Electric stimulation was given through electrode attached to specific acupoints | Device | 10/50HZ TEAS pretreatment |
| fake stimulationPatients were only attached electrodes without electric current | Device | fake stimulation |
Primary outcome
Plasma concentration of epinephrine(ng/L)
Time frame: change of TEAS 0 and 30 minutes
Plasma concentration of norepinephrine(ng/L)
Time frame: change of TEAS 0 and 30 minutes
5 secondary outcomes
Heart rate variability
Time frame: During 30min TEAS
plasma concentration of glucocorticoid(μg/L)
Time frame: change of TEAS 0 and 30 minutes
plasma concentration of aldosterone(ng/L)
Time frame: change of TEAS 0 and 30 minutes
plasma concentration of renin(ng/L)
Time frame: change of TEAS 0 and 30 minutes
plasma concentration of β-endorphin(ng/L)
Time frame: change of TEAS 0 and 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Background: 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.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing TEAS (transcutaneous electrical acupoint stimulation) and fake stimulation in people with Hypotension, 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 5 inclusion and 6 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 20 Nov 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 Qiang Wang (86-29-84775343, wangqiang@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration of epinephrine(ng/L) (time frame: change of TEAS 0 and 30 minutes). The study lists 2 primary outcomes in all. 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 NCT02611388, 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 20 Nov 2015.