NCT03775122

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 15, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

2 months

First QC Date

December 10, 2018

Last Update Submit

February 15, 2019

Conditions

Respiratory Depression

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group 1 sedation group

PLACEBO COMPARATOR

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

Group 2 sedation+TAES group

EXPERIMENTAL

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

Interventions

TAESDEVICE

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

Group 1 sedation groupGroup 2 sedation+TAES group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diansan Su

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33256456DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Yu Weifeng, Dr

    Renji Hospital,School of Medicine,Shanghai Jiaotong University

    STUDY DIRECTOR

Central Study Contacts

chen yongming

CONTACT

13564932181drchelman@hotmail.com

Lu Qi

CONTACT

86(21)68383364rjllb3364@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2018

First Posted

December 13, 2018

Study Start

February 15, 2019

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

February 18, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)