Time to Peak Effect of Propofol in Children

NCT03426462 | Completed Phase 4 DMC

• 1 other identifier: UKBB-2017/032
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

Pharmacodynamic; Permutation Entropy; EEG

Outcome Measures

Primary Outcomes (1)

• Time to peak effect of a propofol bolus

  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

Study Arms (2)

Age 1-6 years

EXPERIMENTAL

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

Age 8-13 years

EXPERIMENTAL

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

Interventions

Propofol DRUG

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

Age 1-6 years; Age 8-13 years

Eligibility Criteria

• Age: 1 Year - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Universitäts Kinderspital beider Basel

Basel, 4051, Switzerland

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Gil Gavel

  Universitäts Kinderspital beider Basel (UKBB)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The analysis of the electroencephalogram will be blinded to the age of the participant.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Age groups 1-6 years will be compared with 8-13 years whilst undergoing propofol anesthesia to detect whether there is indeed a difference in the speed of onset of the hypnotic effect of the drug.

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 8, 2018
• Study Start: April 23, 2018
• Primary Completion: December 4, 2018
• Study Completion: December 4, 2018
• Last Updated: January 30, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)