Time to Peak Effect of Propofol in Children

Phase 4

Completed

• Conditions: Propofol; Child
• Interventions: Drug: Propofol

• Registration Number: NCT03426462
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-25
• Study First Submitted QC: 2018-02-07
• Study First Posted: 2018-02-08
• Study Start: 2018-04-23
• Primary Completion: 2018-12-04
• Study Completion: 2018-12-04
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Age 1-6 years	Propofol	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.
Age 8-13 years	Propofol	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.

Primary Outcome Measures

Name	Time	Method
Time to peak effect of a propofol bolus	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

Trial Locations

Locations (1)

Universitäts Kinderspital beider Basel; 🇨🇭 Basel, Switzerland