Comparing 6 approaches for anesthesia
Official title: End Tidal Carbon Dioxide Concentration and Depth of Anesthesia in Children
Effects of End Tidal Carbon Dioxide Concentration on Depth of Anesthesia in Children Undergoing Total Intravenous Anesthesia
- 6 groups
- One site, in Vancouver
- Recruiting
Interventions
- Other intervention
High normal ETCO2: ETCO2 50 mmHg (+/- 3mmHg)
BIS readings will be recorded continuously at 'High Normal ETCO2' (50 mmHg +/- 3 mmHg). Each patient will be tested at High normal, normal, and low normal ETCO2 levels in a randomized order.
- Other intervention
Normal ETCO2: ETCO2 40 mmHg (+/- 3mmHg)
BIS readings will be recorded continuously at 'Normal ETCO2' (40 mmHg +/- 3 mmHg). Each patient will be tested at High normal, normal, and low normal ETCO2 levels in a randomized order.
- Other intervention
Low Normal ETCO2: ETCO2 30 mmHg (+/- 3mmHg)
BIS readings will be recorded continuously at 'Low Normal ETCO2' (30 mmHg +/- 3 mmHg). Each patient will be tested at High normal, normal, and low normal ETCO2 levels in a randomized order.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
BC Children's Hospital
Vancouver, British Columbia
Eligibility Criteria
See who this study is looking for15 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +American Society of Anesthesiologists (ASA) physical status I and II
- +TIVA technique appropriate throughout induction and maintenance of anesthesia
- +Controlled ventilation via endotracheal tube
- +Anticipated surgical time ≥ 90 minutes: to allow time for anesthetic induction and subsequent testing and washoutWashout periodA gap with no treatment, so the previous one clears your system.Read more → periods at all three EtCO2 levels.
- +Children aged 3 - 11 years undergoing non- or minimally-stimulating elective procedures, defined as anesthesia without skin incision or painful manipulation (e.g., non-invasive imaging, auditory brainstem response testing), middle ear surgery, surgery with effective local or regional anesthesia before surgical incision (e.g dental procedures with local anesthetic infiltration, urology with regional block).
Exclusion
- −Allergy to study drugs (propofol, remifentanil, lidocaine)
- −Need for inhalational induction of anesthesia
- −Sedative premedication
- −Use of ketamine intraoperatively
- −Unable to place BIS electrodes due to surgical siteTrial siteA hospital or clinic where a study is actually run.Read more → or other contraindications (e.g., MRI)
- −Depression of conscious level for any reason
- −BMI \<5th or \>95th centile for age
- −History of obstructive or central sleep apnea
- −Known or suspected raised intracranial pressure
- −Recent or historical traumatic brain injury
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 6 groups in this study.
Groups A, B, C, D, E and F receive one or more of: High normal ETCO2: ETCO2 50 mmHg (+/- 3mmHg), Normal ETCO2: ETCO2 40 mmHg (+/- 3mmHg) and Low Normal ETCO2: ETCO2 30 mmHg (+/- 3mmHg).
Registry label: A: High normal ETCO2, Normal ETCO2, Low normal ETCO2 · B: High normal ETCO2, Low normal ETCO2, Normal ETCO2 · C: Low normal ETCO2, Normal ETCO2, High normal ETCO2 · D: Low normal ETCO2, High normal ETCO2, Normal ETCO2 · E: Normal ETCO2, Low normal ETCO2, High normal ETCO2 · F: Normal ETCO2, High normal ETCO2, Low normal ETCO2
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 3 years to 11 years.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 100 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: Continually assessed throughout the general anesthetic, approximately 1.5-2 hours.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
To determine the effect of end-tidal carbon dioxide concentration (EtCO2) on the depth of anesthesia in children, as measured by BIS — measured over Continually assessed throughout the general anesthetic, approximately 1.5-2 hours.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06303518 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About High normal ETCO2: ETCO2 50 mmHg (+/- 3mmHg)Other
BIS readings will be recorded continuously at 'High Normal ETCO2' (50 mmHg +/- 3 mmHg). Each patient will be tested at High normal, normal, and low normal ETCO2 levels in a randomized order.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Normal ETCO2: ETCO2 40 mmHg (+/- 3mmHg)Other
BIS readings will be recorded continuously at 'Normal ETCO2' (40 mmHg +/- 3 mmHg). Each patient will be tested at High normal, normal, and low normal ETCO2 levels in a randomized order.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Low Normal ETCO2: ETCO2 30 mmHg (+/- 3mmHg)Other
BIS readings will be recorded continuously at 'Low Normal ETCO2' (30 mmHg +/- 3 mmHg). Each patient will be tested at High normal, normal, and low normal ETCO2 levels in a randomized order.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 3 years to 11 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 3 years to 11 years.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Continually assessed throughout the general anesthetic, approximately 1.5-2 hours.
The study as a whole is currently expected to finish around 2026-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Vancouver, British Columbia, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About 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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.