Depth of Anesthesia MonitorNCT03792334
Comparison of BIS and PIS in Children
An observational study of Depth of Anesthesia Monitor, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
Comparison of bispectral index and patient sedation index during general anesthesia in children Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Depth of Anesthesia Monitor
- What is being tested?
- depth of anesthesia
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 10 Jan 2019to 28 Dec 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: general anesthesia
Who may be able to join
- general anesthesia
Who cannot join
- developmental delay
- IICP
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
SNUH
Seoul, Jongnogu, 03080
Seoul National University Hospital
Seoul
About this study
Official title: A Comparison Between Patient State Index (PSI) and Bispectral Index (BIS) as Technologies for Monitor in Depth of Anesthesia in Children: A Prospective Observational Trial
Comparison of bispectral index and patient sedation index during general anesthesia in children
Read the detailed description
the values of BIS and PSI of every 1 minute during general anesthesia in children
- Conditions
- Depth of Anesthesia Monitor
- Being tested
- depth of anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
depth of anesthesiaDevice
monitoring of depth of anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of BIS and PSI
difference of BIS and PSI values
Measured: through study completion, an average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start10 Jan 2019
- Primary completion26 Dec 2019
- Study completion28 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depth of Anesthesia MonitorStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
- Investigators
- Hee-Soo Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792334
- Sponsor's protocol ID
- 1811-172-991
- Status last verified
- Jan 2019
- First submitted
- 28 Dec 2018
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jang YE, Kim EH, Lee JH, Kim JT, Kim HS. Usefulness of bispectral index and patient state index during sevoflurane anesthesia in children: A prospective observational study. Medicine (Baltimore). 2022 Jul 29;101(30):e29925. doi: 10.1097/MD.0000000000029925.
PubMed 35905224
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Patient State Index (PSI) and Bispectral Index (BIS) as Technologies for Monitor in Depth of Anesthesia in Children: A Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT03792334
- Acronym / sponsor ID
- 1811-172-991
- Conditions
- Depth of Anesthesia Monitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 26 Dec 2019 (actual)
- Study completion
- 28 Dec 2019 (actual)
- First posted
- 3 Jan 2019 (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.
Comparison of bispectral index and patient sedation index during general anesthesia in children
Detailed description
the values of BIS and PSI of every 1 minute during general anesthesia in children
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- general anesthesia
Key inclusion criteria (1 listed)
- general anesthesia
Key exclusion criteria (2 listed)
- developmental delay
- IICP
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 |
|---|---|---|
| depth of anesthesiamonitoring of depth of anesthesia | Device | – |
Primary outcome
correlation of BIS and PSI
Time frame: through study completion, an average of 2 hours
difference of BIS and PSI values
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 9 Dec 2020.
- Derived from this study: PubMed 35905224Jang YE, Kim EH, Lee JH, Kim JT, Kim HS. Usefulness of bispectral index and patient state index during sevoflurane anesthesia in children: A prospective observational study. Medicine (Baltimore). 2022 Jul 29;101(30):e29925. doi: 10.1097/MD.0000000000029925.
- 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.
Hee-Soo Kim, MD, PhD principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depth of Anesthesia Monitor, run by Seoul National University Hospital at 2 sites in South Korea.
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 1 inclusion and 2 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 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
correlation of BIS and PSI (time frame: through study completion, an average of 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03792334, which also lists 1 linked publication.
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 9 Dec 2020.