Status:
COMPLETED
Time to Peak Effect of Propofol in Children
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Propofol
Child
Eligibility:
All Genders
1-13 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2018
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03426462
Start Date
April 23 2018
End Date
December 4 2018
Last Update
January 30 2019
Active Locations (1)
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1
Universitäts Kinderspital beider Basel
Basel, Switzerland, 4051