Neurohumoral Mechanism of Deferent Frequency Transcutaneous Electrical Acupoint Stimulation(TEAS)

Hypotension Clinical Trial

Official title:

Neurohumor Mechanism of Deferent Frequency Transcutaneous Electrical Acupoint Stimulation(TEAS): A Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02611388
• Other study ID #: XJH-A-2015-10-28
• Status: Not yet recruiting
• Phase: N/A
• First received: November 15, 2015
• Last updated: November 19, 2015
• Start date: December 2015
• Est. completion date: June 2016

Study information

• Verified date: November 2015
• Source: Xijing Hospital
• Contact: Qiang Wang
• Phone: 86-29-84775343
• Email: wangqiang[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: Chile: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the neurohumoral mechanism of deferent frequency TEAS pretreatment.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 81
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18yrs-65yrs

• ASA 1-2

• Scheduled for elective operation under general anesthesia

• BMI 18-30kg/m2

• Informed consented

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Hypotension

Intervention

Device:
• TEAS (transcutaneous electrical acupoint stimulation)
2/10HZ Electric stimulation was given through electrode attached to specific acupoints
• TEAS (transcutaneous electrical acupoint stimulation)
10/50HZ Electric stimulation was given through electrode attached to specific acupoints
• fake stimulation
Patients were only attached electrodes without electric current

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
wangqiang

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of epinephrine(ng/L)		change of TEAS 0 and 30 minutes	No
Primary	Plasma concentration of norepinephrine(ng/L)		change of TEAS 0 and 30 minutes	No
Secondary	Heart rate variability		During 30min TEAS	No
Secondary	plasma concentration of glucocorticoid(µg/L)		change of TEAS 0 and 30 minutes	No
Secondary	plasma concentration of aldosterone(ng/L)		change of TEAS 0 and 30 minutes	No
Secondary	plasma concentration of renin(ng/L)		change of TEAS 0 and 30 minutes	No
Secondary	plasma concentration of ß-endorphin(ng/L)		change of TEAS 0 and 30 minutes	No