Temperature and Analgesia Monitoring During Cardial Parmonary Bypass

Coronary Artery Disease Clinical Trial

Official title:

Temperature and Analgesia Monitoring During Cardial Parmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03358680
• Other study ID #: ZYLX201706-11025
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: September 19, 2017

Study information

• Verified date: August 2018
• Source: China International Neuroscience Institution
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1. Investigator will apply IOC2 to reflect the depth of analgesic during hypothermia in CPB period.

2. effectiveness of IOC2 monitoring for anesthetic depth versus commonly used vital sign monitoring based on factors such as blood pressure and heart rate.

3. Evaluate the other sedation co-relation measurement, include BIS , IOC2 to reflected the consciousness during the operation.

4. Evaluate the other hemodynamic index, include CO, SVV, CVP, PPV to reflect the circulation function , and the effect to the IOC2 and IOC1.

5. Describe the trend of all the measurement. detect the variation of the index during the temperature change during the CPB.

Description:

In this study,

1. Investigator will apply IOC2 to reflect the depth of analgesic during hypothermia in CPB period.

2. Furthermore, investigator evaluated the effectiveness of IOC2 monitoring for anesthetic depth versus commonly used vital sign monitoring based on factors such as blood pressure and heart rate.

3. Evaluate the other sedation co-relation measurement, include BIS , IOC2 to reflected the consciousness during the operation.

4. Evaluate the other hemodynamic index, include CO, SVV, CVP, PPV to reflect the circulation function , and the effect to the IOC2 and IOC1.

5. Describe the trend of all the measurement. detect the variation of the index during the temperature change during the CPB.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 19, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• undergoing coronary artery bypass surgery

Exclusion Criteria:

• change the surgery planning during the operation

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• noninvasive analgesia measurement
noninvasive analgesia measurement using index of consciousness(IOC2)

Locations

Country	Name	City	State
China	Xuanwu Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China International Neuroscience Institution

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOC2	Index of consciousness 2	1 DAY
Secondary	BIS	to monitor and compare appropriate conscious value	1 DAY
Secondary	IOC1	index of consciousness 1	1 DAY