NCT03665792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

February 11, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

August 4, 2018

Last Update Submit

January 20, 2020

Conditions

Analgesic Adverse ReactionNociceptive PainInhalation; Vapor

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

nociception index qNOXDEVICE

non-invasive, real time, monitoring for nociception stimulation

Also known as: CON , BIS

Eligibility Criteria

Age25 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

only elective thoracoscope surgery patients were enrolled

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bei Liu

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Nociceptive PainRespiratory Aspiration

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesPathologic Processes

Study Officials

  • Xiaohua Wang, MD,PHD

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2018

First Posted

September 11, 2018

Study Start

February 11, 2019

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

January 22, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)