Recruiting

Anesthesia

Sponsor:

University of British Columbia

Code:

NCT06303518

Conditions

Anesthesia

Hypercapnia

Hypocapnia

Eligibility Criteria

Sex: All

Age: 3 - 11

Healthy Volunteers: Accepted

Interventions

High normal ETCO2: ETCO2 50 mmHg (+/- 3mmHg)

Normal ETCO2: ETCO2 40 mmHg (+/- 3mmHg)

Low Normal ETCO2: ETCO2 30 mmHg (+/- 3mmHg)

Study Details

Brief summary:

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.

Conditions

Anesthesia

Hypercapnia

Hypocapnia

Study ID

NCT06303518

Start date

Jun 25, 2024

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 11

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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).
  • 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 washout periods at all three EtCO2 levels.

Exclusion Criteria:

  • Need for inhalational induction of anesthesia
  • Sedative premedication
  • Use of ketamine intraoperatively
  • Unable to place BIS electrodes due to surgical site or other contraindications (e.g., MRI)
  • Allergy to study drugs (propofol, remifentanil, lidocaine)
  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: High normal ETCO2, Normal ETCO2, Low normal ETCO2

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

experimental: High normal ETCO2, Low normal ETCO2, Normal ETCO2

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

experimental: Low normal ETCO2, Normal ETCO2, High normal ETCO2

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

experimental: Low normal ETCO2, High normal ETCO2, Normal ETCO2

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

experimental: Normal ETCO2, Low normal ETCO2, High normal ETCO2

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

experimental: Normal ETCO2, High normal ETCO2, Low normal ETCO2

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

Interventions

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.

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.

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.

Primary outcome measure

  • To determine the effect of end-tidal carbon dioxide concentration (EtCO2) on the depth of anesthesia in children, as measured by BIS. [ Time Frame: Continually assessed throughout the general anesthetic, approximately 1.5-2 hours ]

Central Contacts and Locations

Locations

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

More Information

Sponsor

University of British Columbia

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-05-22.