Time to Peak Effect of Propofol in Children

NCT ID: NCT03426462

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-23
• Study Completion Date: 2018-12-04

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.

Conditions

Propofol; Child

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

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

Interventions

Propofol

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gil Gavel

Role: PRINCIPAL_INVESTIGATOR

Universitäts Kinderspital beider Basel (UKBB)

Locations

Universitäts Kinderspital beider Basel

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

UKBB-2017/032

Identifier Type: -

Identifier Source: org_study_id