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Behavioural Intervention
Carbon Dioxide Levels for Anesthesia in Children
N/A
Recruiting
Led By Christopher A Chin, MBBS, FRCA, FRCP, MA
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Controlled ventilation via endotracheal tube
American Society of Anesthesiologists (ASA) physical status I and II
Timeline
Screening 3 weeks
Treatment Varies
Follow Up continually assessed throughout the general anesthetic, approximately 1.5-2 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial will investigate how different levels of carbon dioxide during intravenous anesthesia affect the sedation or sleepiness levels in children. The study aims to see if adjusting CO2 levels can reduce the amount of
Who is the study for?
This trial is for children aged 3-11 years who need anesthesia for non-painful or minimally painful procedures, like certain ear surgeries or dental work with local anesthetics. They should be generally healthy (ASA status I and II) and the procedure should last at least 90 minutes to allow time for testing.
What is being tested?
The study tests how different CO2 levels during anesthesia affect sleepiness in children, using a BIS monitor that measures brain activity. It compares normal CO2 levels (40 mmHg), high normal levels (50 mmHg), and low normal levels (30 mmHg) to see if they can reduce the amount of anesthetic needed.
What are the potential side effects?
While not explicitly stated, potential side effects may include respiratory changes due to varying CO2 levels. High CO2 might cause deeper sedation while low CO2 could lead to lighter anesthesia than intended.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on a breathing machine through a tube in my windpipe.
Select...
I am in good or mild systemic disease condition according to ASA standards.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ continually assessed throughout the general anesthetic, approximately 1.5-2 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~continually assessed throughout the general anesthetic, approximately 1.5-2 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To determine the effect of end-tidal carbon dioxide concentration (EtCO2) on the depth of anesthesia in children, as measured by BIS.
Secondary study objectives
Patient movement as detected clinically by the surgical or anesthetic team.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Experimental Treatment
Group I: Normal ETCO2, Low normal ETCO2, High normal ETCO2Experimental Treatment3 Interventions
All patients will receive same interventions, in a randomised order.
Group II: Normal ETCO2, High normal ETCO2, Low normal ETCO2Experimental Treatment3 Interventions
All patients will receive same interventions, in a randomised order.
Group III: Low normal ETCO2, Normal ETCO2, High normal ETCO2Experimental Treatment3 Interventions
All patients will receive same interventions, in a randomised order.
Group IV: Low normal ETCO2, High normal ETCO2, Normal ETCO2Experimental Treatment3 Interventions
All patients will receive same interventions, in a randomised order.
Group V: High normal ETCO2, Normal ETCO2, Low normal ETCO2Experimental Treatment3 Interventions
All patients will receive same interventions, in a randomised order.
Group VI: High normal ETCO2, Low normal ETCO2, Normal ETCO2Experimental Treatment3 Interventions
All patients will receive same interventions, in a randomised order.
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,466 Previous Clinical Trials
2,485,356 Total Patients Enrolled
Christopher A Chin, MBBS, FRCA, FRCP, MAPrincipal InvestigatorUniversity of British Columbia
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