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NCT03775122 Clinical Trial

TAES Improve the Function of Respiration and Circulation on Elderly Patients Undergoing Colonoscopy Procedure

Respiratory Depression Clinical Trial

Official title:
Transcutaneous Acupoint Electrical Stimulation Improve the Function of Respiration and Circulation on Elderly Patients Undergoing Colonoscopy Procedure：A Randomized-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03775122
Other study ID # renji-2018-074
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 15, 2019
Est. completion date April 30, 2019

Study information
Verified date February 2019
Source RenJi Hospital
Contact chen yongming
Phone 13564932181
Email drchelman@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To explore the effectiveness of transcutaneous acupuncture electrical stimulation (TAES), a non-invasive modality in improvement of the function of respiration and circulation on elder patient during colonoscopy.

Description:

To assess the function of respiratory and circulation before precondition, during colonoscopy and end of the procedure, blood cortisol and catecholamine levels were measured also.The incidence of airway support, application of vasoactive drug or atropine during procedure were recorded in the meantime.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date April 30, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

1. patients aged 65 or older

2. American Society of Anesthesiologists (ASA) grade I~II

3. consent and voluntary participation in this experiment

4. patients under colonoscopy

5. none allergic to propofol and fentanyl

6. airway assessment for none difficult airway

Exclusion Criteria:

1. Allergic to propofol, fentanyl.

2. ASA is greater than or equal to grade 3

3. Abnormal respiratory tract may cause severe respiratory obstruction

4. unsatisfactory control of hypertension, systolic pressure over 160 millimeter of mercury (mmHg) or diastolic pressure over 100 mmHg

5. Hypotension, systolic pressure below 90 mmHg, heart rate (HR) <50bpm or >100bpm

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• TAES
TAES over acupuncture point neiguan (pericardium 6) for 20min, placebo group only stick the stimulate electrode but no frequency and intensity

Locations
Country Name City State
China Diansan Su Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The percentage of oxygen saturation The percentage of oxygen saturation between the sedation alone and sedation+TAES have at least 2 difference from 20min before lay down to 24hours after performance
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