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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03665792
Other study ID # CINI-ZYLX-201806-11
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 11, 2019
Est. completion date September 1, 2019

Study information

Verified date January 2020
Source China International Neuroscience Institution
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study purpose to observation the sevoflurane analgesia effect, and using nociception real-time monitoring NOX to test the correlation between the sevoflurane and NOX index.


Description:

This study purpose to observation the sevoflurane analgesia effect, and using nociception real-time monitoring NOX to test the analgesia effect of the sevoflurane.

And test the correlation between the sevoflurane and NOX index.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date September 1, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers No
Gender All
Age group 25 Years to 85 Years
Eligibility Inclusion Criteria:

1. Elective thoracoscope surgery patients

2. Age ranging from 25 to 85 years

3. American Society of Anesthesiologists (ASA) Physical Status score of 2 to 4

4. a body mass index (BMI) ranging from 18.5 to 40 kg/m2.

Exclusion Criteria:

1. Clinical diagnosis of Alzheimer's Disease

2. implanted pacemaker

3. Clinical diagnosis of psychiatric diseases

4. Clinical diagnosis of epilepsy

5. Clinical diagnosis of autonomic nervous system disorders which might affect the EEG

Study Design


Intervention

Device:
nociception index qNOX
non-invasive, real time, monitoring for nociception stimulation

Locations

Country Name City State
China Bei Liu 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 The sevoflurane application correlated with the qNOX index The sevoflurane application correlated with the qNOX index, meanwhile reflect the analgesia effect of sevoflurane application through study completion, an average of 1 year
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