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

Not Applicable

• Conditions: Respiratory Depression
• Interventions: Device: TAES

• Registration Number: NCT03775122
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-13
• Status Verified: 2019-02
• Study Start: 2019-02-15
• Last Update Submitted: 2019-02-15
• Last Update Posted: 2019-02-18
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 sedation group	TAES	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 2 sedation+TAES group	TAES	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.

Primary Outcome Measures

Name	Time	Method
The percentage of oxygen saturation	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

Trial Locations

Locations (1)

Diansan Su; 🇨🇳 Shanghai, Shanghai, China