Analgesic Adverse ReactionNCT03665792
The Correlation Between Sevoflurane and qNOX
An observational study of Analgesic Adverse Reaction and Nociceptive Pain, run by China International Neuroscience Institution at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Analgesic Adverse Reaction, Nociceptive Pain, Inhalation; Vapor
- What is being tested?
- nociception index qNOX
- Type of treatment
- Medical device
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 11 Feb 2019to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: only elective thoracoscope surgery patients were enrolled
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prospective Observational Research of the Analgesic Effect of Sevoflurane and the Correlation Between Sevoflurane and qNOX
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.
Read the 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.
- Being tested
- nociception index qNOX
- Medical subject headings
- Nociceptive Pain, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nociception index qNOXDevice
Also called CON , BIS
non-invasive, real time, monitoring for nociception stimulation
What is being measured
The primary outcome is the main question the study is designed to answer.
The sevoflurane application correlated with the qNOX index
The sevoflurane application correlated with the qNOX index, meanwhile reflect the analgesia effect of sevoflurane application
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start11 Feb 2019
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesic Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- China International Neuroscience Institution
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaohua Wang, MD,PHD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665792
- Sponsor's protocol ID
- CINI-ZYLX-201806-11
- Status last verified
- Jan 2020
- First submitted
- 4 Aug 2018
- Last updated
- 22 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective Observational Research of the Analgesic Effect of Sevoflurane and the Correlation Between Sevoflurane and qNOX
- ClinicalTrials.gov ID
- NCT03665792
- Acronym / sponsor ID
- CINI-ZYLX-201806-11
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- China International Neuroscience InstitutionUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- only elective thoracoscope surgery patients were enrolled
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nociception index qNOXAlso: CON , BISnon-invasive, real time, monitoring for nociception stimulation | Device | – |
Primary outcome
The sevoflurane application correlated with the qNOX index
Time frame: through study completion, an average of 1 year
The sevoflurane application correlated with the qNOX index, meanwhile reflect the analgesia effect of sevoflurane application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaohua Wang, MD,PHD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesic Adverse Reaction and Nociceptive Pain, run by China International Neuroscience Institution at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sevoflurane application correlated with the qNOX index (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.