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

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ClinicalTrials.gov Identifier: NCT03775122
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : December 14, 2018
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 : December 12, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Placebo Comparator: Group 1 wake group
Elderly patients under colonoscopy with neither sedation nor real TAES neiguan(pc6)
Device: TAES
TAES over acupuncture point neiguan (pericardium 6) for 20min, placebo group only stick the stimulate electrode but no frequency and intensity

Placebo Comparator: Group 2 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

Sham Comparator: Group 3 wake+TAES group

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

TAES neiguan(pc6): both neiguan(pc6) have the stimulate electrode with 2 Hertz (Hz) frequency, current intensity 6 millimeter ampere (mA) for 20min

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 4 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



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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
Contact: chen yongming 13564932181 drchelman@hotmail.com
Contact: Lu Qi 86(21)68383364 rjllb3364@163.com

Locations
China, Shanghai
Diansan Su Recruiting
Shanghai, Shanghai, China, 200127
Contact: diansan su, Dr.    +862168383702    diansansu@yahoo.com   
Sponsors and Collaborators
RenJi Hospital
Investigators
Study Director: Yu Weifeng, Dr Renji Hospital,School of Medicine,Shanghai Jiaotong University

Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT03775122     History of Changes
Other Study ID Numbers: renji-2018-074
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases