Carbon Dioxide Levels for Anesthesia in Children

Overseen ByVictoria Buswell

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Sedatives, Ketamine

Disqualifiers: Sleep apnea, Brain injury, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adjusting carbon dioxide (CO2) levels during anesthesia affects the depth of children's sleep and their medication needs. By monitoring CO2 with End Tidal Carbon Dioxide Concentration Monitoring, researchers hope to enhance anesthesia experiences by potentially reducing medication use, side effects, and costs. This approach could benefit children undergoing non-invasive or minimally invasive procedures that require anesthesia but not major surgery. Children who are generally healthy and undergoing procedures like imaging or minor surgeries without skin incisions might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve anesthesia safety and effectiveness for children.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications. However, it does exclude those who need sedative premedication or use ketamine during the procedure.

What prior data suggests that this method is safe for children?

Research has shown that monitoring carbon dioxide (CO2) levels at the end of a breath is generally safe and well-tolerated in children. Studies have found that during procedures like esophagogastroduodenoscopy, CO2 levels might temporarily rise without causing long-term problems.

End-tidal CO2 monitoring helps doctors assess a child's breathing under anesthesia. This method reliably evaluates how air moves in and out of the lungs in children. One study emphasized the importance of this monitoring during anesthesia, as it supports patient safety and improves outcomes.

In summary, current research supports the safety of using end-tidal CO2 monitoring in children. However, as with any medical procedure, discussing potential risks and benefits with a healthcare provider is important.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial?

Researchers are excited about monitoring end tidal carbon dioxide (ETCO2) levels during anesthesia in children because it could enhance safety and precision. Unlike traditional methods that might not capture real-time changes in CO2 levels, this approach provides continuous monitoring, allowing for immediate adjustments in anesthesia delivery. This could potentially minimize risks and improve outcomes by ensuring each child maintains optimal CO2 levels throughout the procedure. By exploring different ETCO2 concentrations, researchers aim to determine the best practices for maintaining stable vital signs and preventing complications during pediatric surgeries.

What evidence suggests that this trial's treatments could be effective for anesthesia in children?

Research has shown that checking carbon dioxide (CO2) levels during anesthesia helps determine how deeply a child is asleep. Studies have found that CO2 monitoring lowers the risk of low oxygen levels, making it easier for children to wake up safely from anesthesia. It may also reduce the amount of anesthetic needed, which can lessen side effects and costs. This method has shown promise in adults and could benefit children as well. In this trial, all patients will receive CO2 monitoring at different levels (low normal, normal, and high normal) in a randomized order. CO2 monitoring could improve safety and effectiveness during surgeries for kids.¹ ² ⁴ ⁶ ⁷

Who Is on the Research Team?

Christopher A Chin, MBBS, FRCA, FRCP, MA

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My child is 3-11 years old and will have a minor surgery or procedure without major cuts.

I am on a breathing machine through a tube in my windpipe.

I am in good or mild systemic disease condition according to ASA standards.

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total intravenous anesthesia with varying levels of end-tidal carbon dioxide concentration to assess its effect on the depth of anesthesia, as measured by BIS.

1.5-2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after anesthesia, including any side effects or complications.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

End Tidal Carbon Dioxide Concentration Monitoring

Trial Overview 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.

How Is the Trial Designed?

6Treatment groups

Experimental Treatment

Group I: Normal ETCO2, Low normal ETCO2, High normal ETCO2Experimental Treatment3 Interventions