- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03792334
Comparison of BIS and PIS in Children
December 8, 2020 updated by: Hee-Soo Kim, Seoul National University Hospital
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
the values of BIS and PSI of every 1 minute during general anesthesia in children
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Seoul National University Hospital
-
-
Jongnogu
-
Seoul, Jongnogu, Korea, Republic of, 03080
- SNUH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
general anesthesia
Description
Inclusion Criteria:
- general anesthesia
Exclusion Criteria:
- developmental delay
- IICP
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
correlation of BIS and PSI
Time Frame: through study completion, an average of 2 hours
|
difference of BIS and PSI values
|
through study completion, an average of 2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2019
Primary Completion (Actual)
December 26, 2019
Study Completion (Actual)
December 28, 2019
Study Registration Dates
First Submitted
December 28, 2018
First Submitted That Met QC Criteria
January 1, 2019
First Posted (Actual)
January 3, 2019
Study Record Updates
Last Update Posted (Actual)
December 9, 2020
Last Update Submitted That Met QC Criteria
December 8, 2020
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1811-172-991
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depth of Anesthesia Monitor
-
National Taiwan University HospitalCompleted
-
Charite University, Berlin, GermanyCompletedDepth of AnesthesiaGermany
-
Charite University, Berlin, GermanyCompletedDepth of AnesthesiaGermany
-
Pontificia Universidad Catolica de ChileCompletedSurgery | Anesthesia | Depth of Anesthesia | NeonateChile
-
NeuroWave Systems Inc.Fraser Health; U.S. Army Medical Research Acquisition ActivityCompletedDepth of Anesthesia (DOA)Canada
-
Cleveland Clinic Abu DhabiMasimo CorporationCompletedDepth of Anesthesia MonitoringUnited Arab Emirates
-
Erasmus Medical CenterRecruitingAnesthesia | Depth of Hypnosis MonitoringNetherlands
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingIntraoperative Monitoring | Depth of AnesthesiaChina
-
Pontificia Universidad Catolica de ChileCompletedAging | Propofol | Electroencephalography | Depth of AnesthesiaChile
-
Military Institute of Medicine, PolandCompletedMonitoring of Depth of Anesthesia | AAI IndexPoland
Clinical Trials on depth of anesthesia
-
Shengjing HospitalRecruitingGeneral Anesthesia | DreamingChina
-
Northern State Medical UniversityCompletedHeart Valve Diseases
-
University of PecsRecruiting
-
Duke UniversityCompletedEmergence AgitationUnited States
-
Brno University HospitalMasaryk UniversityRecruiting
-
Tepecik Training and Research HospitalActive, not recruitingSedation Complication | Anesthesia Awareness | Acute Respiratory Distress Syndrome Due to COVID-19Turkey
-
Imam Abdulrahman Bin Faisal UniversityKing Saud UniversityCompletedThoracic Surgery | One Lung Ventilation | Left-sided Double Lumen TubeSaudi Arabia
-
Auckland City HospitalNot yet recruitingDelirium | Anesthesia | Cognitive Decline | Cognition Disorder | Surgery-Complications | Delirium, Postoperative
-
Duke UniversityCompletedExercise | Hypercapnia | Immersion | Diving | Nitrogen NarcosisUnited States
-
Tianjin Medical University Second HospitalCompleted