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Sponsors and Collaborators: |
University of British Columbia Canadian Anesthesiologists' Society |
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Information provided by: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00832013 |
Advances in health care require that more children are given sedation to allow doctors to perform investigations or minor procedures. Sedation drugs have traditionally been given orally (swallowed) by children. However, oral sedation drugs have unpredictable characteristics, such as duration of sedation, which may result in difficulties performing the planned procedure. Anesthetic drugs are now invariably used for sedation in children. These are given through an IV (skinny plastic tube inserted in to a vein). Propofol (white liquid) is the anesthetic drug most commonly used for sedation at BC Children's Hospital for sedation. Propofol has several advantages, including an accurately controllable depth of sedation (how deeply asleep), minimal effect on the heart and circulation and control of reflexes (e,g coughing) during the procedure. Propofol also promotes rapid recovery with less sickness and an earlier return to normal functioning following the procedure. While propofol has many advantages it can cause respiratory depression (reduced breathing rate). This reduction in breathing is more common if propofol is given quickly. When your child is given propofol for their proposed procedure this is performed by a pediatric anesthesiologist who is skilled in supporting breathing should this be required. If your child does not participate in this study they will still receive propofol administered by the anesthesiologist as this is our usual practice. It would be routine to administer the propofol rapidly and then support breathing for a few minutes. This is very safe in the hands of an expert anesthesiologist but can be sometimes more risky in other settings where extensive monitoring and anesthesiologists are not available. This is the setting that propofol is used in many institutions. Our goal is to determine how quickly propofol can be given without reducing breathing to the point that help with breathing is required.
Condition | Intervention |
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Sedation |
Drug: Propofol |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacodynamics Study |
Official Title: | Safe Administration of Propofol for Sedation in Children |
Estimated Enrollment: | 120 |
Study Start Date: | June 2008 |
Study Completion Date: | August 2009 |
Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Propofol 1 % at a dose of 4mg/kg will be administered intravenously via a standard Medex Protégé® 3010 (Medex-A Furon. Healthcare Company, Duluth, GA, USA) infusion pump at a constant rate determined by the randomization schedule. Fresh gas flow will be maintained at 6 l/min throughout the induction procedure with the FiO2 increased to 0.5. Full cardiovascular, respiratory and EEG monitoring will continue during induction of anesthesia. Once the loading dose of propofol has been delivered the propofol infusion will be maintained at a rate of 200mcg/kg/min or as determined by the attending anesthesiologist whilst the end-point respiratory responses are observed.
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Drug: Propofol
See detailed description
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2: Active Comparator
Same procedure as above. These subjects will be stratified by age and randomized, using the Biased Coin Design (BCD) principle to determine the infusion rate of propofol for delivery of the induction dose.
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Drug: Propofol
See detailed description
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Ages Eligible for Study: | 6 Years to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
All ASA category 1 and 2 children aged 6-15y for elective upper or lower gastrointestinal endoscopic investigations to be performed under sedation. Stratification by age (<9y, 9-12y, >12y) will be performed to ensure balanced allocation of age groups and allow for identification of age and weight specific effects.
Exclusion Criteria:
Canada, British Columbia | |
BC Children's Hospital, Department of Anesthesia | |
Vancouver, British Columbia, Canada, V6H 3V4 |
Principal Investigator: | Mark Ansermino, MD | University of British Columbia |
Study Director: | Jon McCormack | University of British Columbia |
Study Director: | Eleanor Reimer | University of British Columbia |
Study Director: | Guy Dumont | University of British Columbia |
Study Director: | Prasad Shrawane | University of British Columbia |
Study Director: | Rollin Brant | University of British Columbia |
Responsible Party: | University of British Columbia ( Dr. Mark Ansermino ) |
Study ID Numbers: | H07-02846 |
Study First Received: | January 27, 2009 |
Last Updated: | August 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00832013 History of Changes |
Health Authority: | Canada: Health Canada |
Propofol sedation pediatric Induction of sedation |
Anesthetics, Intravenous Anesthetics, General Hypnotics and Sedatives |
Central Nervous System Depressants Anesthetics Propofol |
Anesthetics, Intravenous Anesthetics, General Therapeutic Uses Hypnotics and Sedatives Physiological Effects of Drugs |
Central Nervous System Depressants Anesthetics Propofol Central Nervous System Agents Pharmacologic Actions |