Back to resultsCorrelation Between Exhaled Propofol Concentration With Plasma Concentration in Children
Primary Purpose
Eye Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Edmon
Sponsored by
About this trial
This is an interventional basic science trial for Eye Diseases
Eligibility Criteria
Inclusion Criteria:
- elective eye surgey
Exclusion Criteria:
- known propofol hypersensitivity
Sites / Locations
- Oslo University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
propofol
Arm Description
propofol general anesthesia, exhaled measurement of propofol
Outcomes
Primary Outcome Measures
Propofol plasma concentration versus simultaneous exhaled concentration
repeated blood samples of propofol concentration
Secondary Outcome Measures
Propofol exhaled correlation versus Bispectral Index value (BIS)
repeated blood samples of propofol concentration
Full Information
NCT ID
NCT04150432
First Posted
October 30, 2019
Last Updated
November 1, 2019
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04150432
Brief Title
Correlation Between Exhaled Propofol Concentration With Plasma Concentration in Children
Official Title
Propofol in Expiratory Air, a Comparison With Plasma Propofol, BIS Value and Calculated Plasma Concentration During General Anesthesia in Children
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Children due for elective eye surgery in propofol based anesthesia will be kept at steady state propofol infusion for maintenance, ventilation via endotracheal tube. Exhaled propofol will be measured continously by Edmon (R) (BBraun) monitor and compared with arterial plasma samples of propofol, drawn 3-5 times during the procedure.
Detailed Description
The primary objective of the study is to determine the correlation between simultaneous concentrations of propofol in plasma and expiratory air in children during general anesthesia.
Key secondary objectives include correlating plasma and exhaled measurements of propofol with electroencephalogram (BIS) values and computer estimated propofol concentrations in plasma and brain (TCI: target control infusion) Primary endpoint: Exhaled air and plasma concentration ratios of propofol during general anesthesia in children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Diseases
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Consecutive patients will participate in the study
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
propofol
Arm Type
Experimental
Arm Description
propofol general anesthesia, exhaled measurement of propofol
Intervention Type
Device
Intervention Name(s)
Edmon
Intervention Description
New device for exhaled propofol concentration measurements
Primary Outcome Measure Information:
Title
Propofol plasma concentration versus simultaneous exhaled concentration
Description
repeated blood samples of propofol concentration
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
Propofol exhaled correlation versus Bispectral Index value (BIS)
Description
repeated blood samples of propofol concentration
Time Frame
5 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
elective eye surgey
Exclusion Criteria:
known propofol hypersensitivity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johan Raeder, PhD, MD
Phone
004792249669
Email
johan.rader@medisin.uio.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Thagaard, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johan Raeder, MD, PhD
Phone
004792249669
Email
johan.rader@medisin.uio.no
12. IPD Sharing Statement
Plan to Share IPD
No
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Correlation Between Exhaled Propofol Concentration With Plasma Concentration in Children
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