Temperature and Analgesia Monitoring During Cardial Parmonary Bypass

August 4, 2018 updated by: China International Neuroscience Institution
  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Xuanwu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

the patients schedule undergoing coronary artery bypass surgery

Description

Inclusion Criteria:

  • undergoing coronary artery bypass surgery

Exclusion Criteria:

  • change the surgery planning during the operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOC2
Time Frame: 1 DAY
Index of consciousness 2
1 DAY

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BIS
Time Frame: 1 DAY
to monitor and compare appropriate conscious value
1 DAY
IOC1
Time Frame: 1 DAY
index of consciousness 1
1 DAY

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China International Neuroscience Institution

Investigators

  • Principal Investigator: Zhaolong Tian, MS, Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 19, 2017

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

November 29, 2017

First Posted (Actual)

November 30, 2017

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 4, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZYLX201706-11025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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