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

Primary Purpose

Respiratory Depression

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

TAES

About this trial

This is an interventional treatment trial for Respiratory Depression

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

patients aged 65 or older
American Society of Anesthesiologists (ASA) grade I~II
consent and voluntary participation in this experiment
patients under colonoscopy
none allergic to propofol and fentanyl
airway assessment for none difficult airway

Exclusion Criteria:

Allergic to propofol, fentanyl.
ASA is greater than or equal to grade 3
Abnormal respiratory tract may cause severe respiratory obstruction
unsatisfactory control of hypertension, systolic pressure over 160 millimeter of mercury (mmHg) or diastolic pressure over 100 mmHg
Hypotension, systolic pressure below 90 mmHg, heart rate (HR) <50bpm or >100bpm

Sites / Locations

Diansan SuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Group 1 sedation group

Group 2 sedation+TAES group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The percentage of oxygen saturation

The percentage of oxygen saturation between the sedation alone and sedation+TAES have at least 2 difference

Secondary Outcome Measures

Full Information

NCT ID

NCT03775122

First Posted

December 10, 2018

Last Updated

February 15, 2019

Sponsor

RenJi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03775122

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 15, 2019 (Anticipated)

Primary Completion Date

April 30, 2019 (Anticipated)

Study Completion Date

April 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1 sedation group

Arm Type

Placebo Comparator

Arm Description

Arm Title

Group 2 sedation+TAES group

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

TAES

Intervention Description

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

Primary Outcome Measure Information:

Title

The percentage of oxygen saturation

Description

The percentage of oxygen saturation between the sedation alone and sedation+TAES have at least 2 difference

Time Frame

from 20min before lay down to 24hours after performance

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients aged 65 or older American Society of Anesthesiologists (ASA) grade I~II consent and voluntary participation in this experiment patients under colonoscopy none allergic to propofol and fentanyl airway assessment for none difficult airway Exclusion Criteria: Allergic to propofol, fentanyl. ASA is greater than or equal to grade 3 Abnormal respiratory tract may cause severe respiratory obstruction unsatisfactory control of hypertension, systolic pressure over 160 millimeter of mercury (mmHg) or diastolic pressure over 100 mmHg Hypotension, systolic pressure below 90 mmHg, heart rate (HR) <50bpm or >100bpm

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

chen yongming

Phone

13564932181

drchelman@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Lu Qi

Phone

86(21)68383364

rjllb3364@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yu Weifeng, Dr

Organizational Affiliation

Renji Hospital,School of Medicine,Shanghai Jiaotong University

Official's Role

Study Director

Facility Information:

Facility Name

Diansan Su

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200127

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

diansan su, Dr.

Phone

+862168383702

diansansu@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33256456

Citation

Chen Y, Gong Y, Huai X, Gu X, Su D, Yu W, Xie H. Effects of transcutaneous electrical acupuncture point stimulation on peripheral capillary oxygen saturation in elderly patients undergoing colonoscopy with sedation: a prospective randomized controlled trial. Acupunct Med. 2021 Aug;39(4):292-298. doi: 10.1177/0964528420960479. Epub 2020 Nov 30.

Results Reference

derived

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

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