Carbon Dioxide Levels for Anesthesia in Children

Overseen By Victoria 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1.5-2 hours

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment End Tidal Carbon Dioxide Concentration Monitoring in children?

Research shows that monitoring end-tidal carbon dioxide (ETCO2) levels is useful in estimating arterial carbon dioxide levels in children during anesthesia, helping to adjust ventilation settings effectively. Although there can be discrepancies, ETCO2 monitoring remains a fundamental tool for ensuring proper ventilation in pediatric anesthesia. ^{1 2 3 4 5}

Is monitoring carbon dioxide levels during anesthesia safe for children?

Monitoring carbon dioxide levels in children during anesthesia is generally considered safe and can help detect critical incidents early. It provides an early warning system for potential problems, although there is a risk of overestimating carbon dioxide levels, which could lead to unrecognized low carbon dioxide levels in the blood. ^{1 4 6 7 8}

How does End Tidal Carbon Dioxide Concentration Monitoring differ from other treatments for monitoring carbon dioxide levels in children under anesthesia?

End Tidal Carbon Dioxide Concentration Monitoring is unique because it provides a non-invasive way to estimate arterial carbon dioxide levels by measuring the carbon dioxide in the breath at the end of an exhalation. This method is particularly useful in pediatric anesthesia as it helps monitor ventilation without needing invasive blood gas tests, although it may not always perfectly reflect arterial carbon dioxide levels. ^{1 4 5 9 10}

What is the purpose of this trial?

Carbon Dioxide (CO2) is a by-product of metabolism and is removed from the body when we breathe out. High levels of CO2 can affect the nervous system and cause us to be sleepy or sedated. Research suggests that high levels of CO2 may benefit patients who are asleep under anesthesia, such as by reducing infection rates, nausea, or recovery from anesthesia . CO2 may also reduce pain signals or the medication required to keep patients asleep during anesthesia; this has not been researched in children. During general anesthesia, anesthesiologists keep patients asleep with anesthetic gases or by giving medications into a vein. These drugs can depress breathing; therefore, an anesthesiologist will control breathing (ventilation) with an artificial airway such as an endotracheal tube. Changes in ventilation can alter the amount of CO2 removed from the body. The anesthesiologist may also monitor a patient's level of consciousness using a 'Depth of Anesthesia Monitor' such as the Bispectral Index (BIS), which analyzes a patient's brain activity and generates a number to tell the anesthesiologist how asleep they are. The investigator's study will test if different levels of CO2 during intravenous anesthesia are linked with different levels of sedation or sleepiness in children, as measured by BIS. If so, this could reduce the amount of anesthetic medication the child receives. Other benefits may be decreased medication costs, fewer side effects, and a positive environmental impact by using less disposable anesthesia equipment.

Research Team

Christopher A Chin, MBBS, FRCA, FRCP, MA

Principal Investigator

University of British Columbia

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Normal ETCO2, Low normal ETCO2, High normal ETCO2 Experimental Treatment 3 Interventions

All patients will receive same interventions, in a randomised order.

Group II: Normal ETCO2, High normal ETCO2, Low normal ETCO2 Experimental Treatment 3 Interventions

All patients will receive same interventions, in a randomised order.

Group III: Low normal ETCO2, Normal ETCO2, High normal ETCO2 Experimental Treatment 3 Interventions

All patients will receive same interventions, in a randomised order.

Group IV: Low normal ETCO2, High normal ETCO2, Normal ETCO2 Experimental Treatment 3 Interventions

All patients will receive same interventions, in a randomised order.

Group V: High normal ETCO2, Normal ETCO2, Low normal ETCO2 Experimental Treatment 3 Interventions

All patients will receive same interventions, in a randomised order.

Group VI: High normal ETCO2, Low normal ETCO2, Normal ETCO2 Experimental Treatment 3 Interventions

All patients will receive same interventions, in a randomised order.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Noninvasive monitoring of end-tidal CO2 via nasal cannulas in spontaneously breathing children during the perioperative period. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Capnography during sedation/analgesia in the pediatric emergency department. [2019]

3. India pubmed.ncbi.nlm.nih.gov

Correlation between bispectral index, end-tidal anaesthetic gas concentration and difference in inspired-end-tidal oxygen concentration as measures of anaesthetic depth in paediatric patients posted for short surgical procedures. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Arterial to end-tidal carbon dioxide difference in children undergoing mechanical ventilation of the lungs during general anaesthesia. [2019]

5. France pubmed.ncbi.nlm.nih.gov

[Capnography in pediatric anesthesia: pitfalls and applications]. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

End-tidal carbon dioxide monitoring in the detection of anesthesia-related critical incidents. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Microstream capnography improves patient monitoring during moderate sedation: a randomized, controlled trial. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Intraoperative events diagnosed by expired carbon dioxide monitoring in children. [2019]

9. Canada pubmed.ncbi.nlm.nih.gov

Arterial to end-tidal carbon dioxide tension difference in children under halothane anaesthesia. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

[Measurement of end-expiratory carbon dioxide values in pediatric anesthesia]. [2013]