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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Unknown

Conditions

Respiratory Depression

Treatments

Device: TAES

Study type

Interventional

Funder types

Other

Identifiers

NCT03775122
renji-2018-074

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups, including a placebo group

Group 1 sedation group
Placebo Comparator group
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.
Treatment:
Device: TAES
Group 2 sedation+TAES group
Experimental group
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.
Treatment:
Device: TAES

Trial contacts and locations

1

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Central trial contact

Lu Qi; chen yongming

Data sourced from clinicaltrials.gov

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