Correlation Between Exhaled Propofol Concentration With Plasma Concentration in Children

Propofol in Expiratory Air, a Comparison With Plasma Propofol, BIS Value and Calculated Plasma Concentration During General Anesthesia in Children

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.

Study Overview

• Status: Unknown
• Conditions: Eye Diseases
• Intervention / Treatment: Device: Edmon

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johan Raeder, PhD, MD; Phone Number: 004792249669; Email: johan.rader@medisin.uio.no

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Recruiting
    • Oslo University Hospital
    • Contact: Johan Raeder, MD, PhD; Phone Number: 004792249669; Email: johan.rader@medisin.uio.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• elective eye surgey

Exclusion Criteria:

• known propofol hypersensitivity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: propofol; propofol general anesthesia, exhaled measurement of propofol	Device: Edmon; New device for exhaled propofol concentration measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Propofol plasma concentration versus simultaneous exhaled concentration	repeated blood samples of propofol concentration	5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Propofol exhaled correlation versus Bispectral Index value (BIS)	repeated blood samples of propofol concentration	5 hours

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Study Director: Kristin Thagaard, MD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases
• Other Study ID Numbers: Exhaled propofol Children

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