Time to Peak Effect of Propofol in Children

Child Clinical Trial

— TPEPC  

Official title:

Time to Peak Effect of Propofol in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426462
• Other study ID #: UKBB-2017/032
• Status: Completed
• Phase: Phase 4
• Start date: April 23, 2018
• Est. completion date: December 4, 2018

Study information

• Verified date: January 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 4, 2018
• Est. primary completion date: December 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child
• Propofol

Intervention

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

Locations

Country	Name	City	State
Switzerland	Universitäts Kinderspital beider Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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