Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775122
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Respiratory Depression Device: TAES Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Transcutaneous Acupoint Electrical Stimulation Improve the Function of Respiration and Circulation on Elderly Patients Undergoing Colonoscopy Procedure:A Randomized-controlled Trial
Estimated Study Start Date : February 15, 2019
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Placebo Comparator: Group 1 sedation group

Elderly patients under colonoscopy with sedation, but no real TAES neiguan(pc6)

sedation is using the typical protocol for the following: Slowly peripheral intravenous injection(0.5ml/s) of fentanyl 50μg, then followed with 1.5-2.5mg/kg propofol until loss of eyelash reflex, the Observer's Assessment of Alertness/Sedation Scale (OAAS) score Level3-5.

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

Experimental: Group 2 sedation+TAES group

Elderly patients under colonoscopy both have TAES neiguan(pc6) and sedation.

sedation is begun followed TAES. sedation is same as group2 do. TAES is same as group3 do.

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




Primary Outcome Measures :
  1. The percentage of oxygen saturation [ Time Frame: from 20min before lay down to 24hours after performance ]
    The percentage of oxygen saturation between the sedation alone and sedation+TAES have at least 2 difference



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775122


Contacts
Layout table for location contacts
Contact: chen yongming 13564932181 drchelman@hotmail.com
Contact: Lu Qi 86(21)68383364 rjllb3364@163.com

Locations
Layout table for location information
China, Shanghai
Diansan Su Recruiting
Shanghai, Shanghai, China, 200127
Contact: diansan su, Dr.    +862168383702    diansansu@yahoo.com   
Sponsors and Collaborators
RenJi Hospital
Investigators
Layout table for investigator information
Study Director: Yu Weifeng, Dr Renji Hospital,School of Medicine,Shanghai Jiaotong University
Layout table for additonal information
Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT03775122    
Other Study ID Numbers: renji-2018-074
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases