Time to Peak Effect of Propofol in Children (TPEPC)

January 29, 2019 updated by: University Hospital, Basel, Switzerland
In order to determine the speed of onset of the anaesthetic propofol in children, investigators will compare the two age groups 1-6 years vs 8-13 years. The primary outcome measure is the time to peak effect of a bolus of proposal, which is measured by analysing the electroencephalogram by using the permutation entropy. Further pharmacodynamic modelling will enable investigators to quantify the difference with age in the hypnotic effect of propofol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

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

  • Switzerland
      • Basel, Switzerland, 4051
        • Universitäts Kinderspital Beider Basel

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

1 year to 13 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The study population will be healthy children in the ranges of 1-6 and 8-13 years of age having surgery with American Society of Anaesthesia (ASA) grades I-II (ie. no prior functional limitation due to comorbidities) that fulfil the following points:
  • parental written consent obtained at least a day prior to begin of the subject's study episode; and
  • the child is appropriate for induction and maintenance of anaesthesia with propofol.

Exclusion Criteria:

  • Any significant subject co-morbidity (ASA III or IV);
  • Withdrawal of consent/assent at any point in the study;
  • Failure to cannulate a peripheral vein prior to induction after two attempts;
  • Any other reason making IV induction with propofol impossible;
  • Allergy to propofol (or its emulsion carrier), Eutectic Mixture of Local Anesthetics (EMLA) cream or Nitrous Oxide (N2O);
  • previous enrolment in the study;
  • Any anaesthetic problem that would take precedence over completion of the study protocol.

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

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Age 1-6 years

Induction of anesthesia with propofol using infusion pumps that are programmed with a pharmacokinetic model to achieve a calculated plasma concentration of the drug; this is followed by two anesthetic deepening episodes.

The target plasma concentrations achieved, as calculated by the programmed pump, is exactly the same in both age groups.
Drug: Propofol
Induction of anesthesia and two further deepening episodes will be performed whilst recording the electroencephalogram.
Experimental: Age 8-13 years

Induction of anesthesia with propofol using infusion pumps that are programmed with a pharmacokinetic model to achieve a calculated plasma concentration of the drug; this is followed by two anesthetic deepening episodes.

The target plasma concentrations achieved, as calculated by the programmed pump, is exactly the same in both age groups.
Drug: Propofol
Induction of anesthesia and two further deepening episodes will be performed whilst recording the electroencephalogram.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to peak effect of a propofol bolus
Time Frame: up to 20 minutes from baseline until peak effect following second bolus administration
This is the time from the start of the propofol bolus administration to the maximal suppression of the electroencephalogram; per subject two boli will be administered
up to 20 minutes from baseline until peak effect following second bolus administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Gil Gavel, Universitäts Kinderspital Beider Basel (UKBB)

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)

April 23, 2018

Primary Completion (Actual)

December 4, 2018

Study Completion (Actual)

December 4, 2018

Study Registration Dates

First Submitted

January 25, 2018

First Submitted That Met QC Criteria

February 7, 2018

First Posted (Actual)

February 8, 2018

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKBB-2017/032

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

product manufactured in and exported from the U.S.

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.

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