NCT02611388

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

4 months

First QC Date

November 15, 2015

Last Update Submit

November 19, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • Plasma concentration of epinephrine(ng/L)

    change of TEAS 0 and 30 minutes

  • Plasma concentration of norepinephrine(ng/L)

    change of TEAS 0 and 30 minutes

Secondary Outcomes (5)

  • Heart rate variability

    During 30min TEAS

  • plasma concentration of glucocorticoid(μg/L)

    change of TEAS 0 and 30 minutes

  • plasma concentration of aldosterone(ng/L)

    change of TEAS 0 and 30 minutes

  • plasma concentration of renin(ng/L)

    change of TEAS 0 and 30 minutes

  • plasma concentration of β-endorphin(ng/L)

    change of TEAS 0 and 30 minutes

Study Arms (3)

2/10HZ TEAS pretreatment

EXPERIMENTAL

Patients were given 30min of 2/10HZ TEAS before anesthesia

Device: TEAS (transcutaneous electrical acupoint stimulation)

10/50HZ TEAS pretreatment

EXPERIMENTAL

Patients were given 30min of 10/50HZ TEAS before anesthesia

Device: TEAS (transcutaneous electrical acupoint stimulation)

fake stimulation

SHAM COMPARATOR

Patients were only attached electrodes without electric current

Device: fake stimulation

Interventions

2/10HZ Electric stimulation was given through electrode attached to specific acupoints

2/10HZ TEAS pretreatment

Patients were only attached electrodes without electric current

fake stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18yrs-65yrs
  • ASA 1-2
  • Scheduled for elective operation under general anesthesia
  • BMI 18-30kg/m2
  • Informed consented

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 26170347BACKGROUND

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 15, 2015

First Posted

November 20, 2015

Study Start

December 1, 2015

Primary Completion

April 1, 2016

Study Completion

June 1, 2016

Last Updated

November 20, 2015

Record last verified: 2015-11