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

NCT ID: NCT03775122

Last Updated: 2019-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-15

Study Completion Date

2019-04-30

Brief Summary

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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

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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.

Conditions

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Respiratory Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

TAES

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

TAES

Intervention Type DEVICE

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

Interventions

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TAES

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu Weifeng, Dr

Role: STUDY_DIRECTOR

Renji Hospital,School of Medicine,Shanghai Jiaotong University

Locations

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Diansan Su

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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chen yongming

Role: CONTACT

13564932181

Lu Qi

Role: CONTACT

86(21)68383364

Facility Contacts

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diansan su, Dr.

Role: primary

+862168383702

References

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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.

Reference Type DERIVED
PMID: 33256456 (View on PubMed)

Other Identifiers

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renji-2018-074

Identifier Type: -

Identifier Source: org_study_id

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