The Correlation Between Sevoflurane and qNOX | NCT03665792

Studies
The Correlation Between Sevoflurane and qNOX

NCT03665792

Sponsor

China International Neuroscience Institution

Status

Completed

Last Update Posted

Jan 22, 2020Actual

Enrollment

58Actual

Phase

Not provided

Conditions

Analgesic Adverse Reaction
Nociceptive Pain
Inhalation; Vapor

Interventions

nociception index qNOX

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 11, 2019Actual

Primary Completion Date

Sep 1, 2019Actual

Completion Date

Sep 1, 2019Actual

First Submitted Date

Aug 4, 2018

First Submission Date that Met QC Criteria

Sep 8, 2018

First Posted Date

Sep 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2020

Last Update Posted Date

Jan 22, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nociception index qNOX	Device	non-invasive, real time, monitoring for nociception stimulation		CON , BIS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective thoracoscope surgery patients
Age ranging from 25 to 85 years
American Society of Anesthesiologists (ASA) Physical Status score of 2 to 4
a body mass index (BMI) ranging from 18.5 to 40 kg/m2.

Exclusion Criteria:

Clinical diagnosis of Alzheimer's Disease
implanted pacemaker
Clinical diagnosis of psychiatric diseases
Clinical diagnosis of epilepsy
Clinical diagnosis of autonomic nervous system disorders which might affect the EEG

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

only elective thoracoscope surgery patients were enrolled

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiaohua Wang, MD,PHD	Xuanwu Hospital, Beijing	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bei Liu		Beijing	Beijing Municipality	100053	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059226	Nociceptive Pain
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided