NCT04150432

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

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

October 30, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

October 30, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

October 30, 2019

Last Update Submit

March 5, 2026

Conditions

Eye Diseases

Outcome Measures

Primary Outcomes (2)

  • Propofol plasma concentration versus simultaneous exhaled concentration

    repeated blood samples of propofol concentration

    5 hours

  • Realtionship between Paedfusor-estimated propofol concentration and measured concentration in plasma samples

    During general anaesthesia

Secondary Outcomes (1)

  • Propofol exhaled correlation versus Bispectral Index value (BIS)

    5 hours

Study Arms (1)

propofol

EXPERIMENTAL

propofol general anesthesia, exhaled measurement of propofol

Device: Edmon

Interventions

EdmonDEVICE

New device for exhaled propofol concentration measurements

propofol

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • elective eye surgey

You may not qualify if:

  • known propofol hypersensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Eye Diseases

Study Officials

  • Kristin Thagaard, MD

    Oslo University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Consecutive patients will participate in the study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Consultant

Study Record Dates

First Submitted

October 30, 2019

First Posted

November 4, 2019

Study Start

October 30, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2021

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)