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Completed

NCT Number: NCT03426462

Time to Peak Effect of Propofol in Children

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.

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Key information

Conditions

Propofol Child

Age range

1 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universitäts Kinderspital beider Basel

Basel, 4051, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol

Drug

Induction of anesthesia and two further deepening episodes will be performed whilst recording the electroencephalogram.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: TPEPC

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 8, 2018
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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