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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

100

participants targeted

Target at P50-P75 for not_applicable

Timeline

7mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

Study Progress77%

Jun 2024Dec 2026

First Submitted

Initial submission to the registry

February 26, 2024

Completed

15 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed

4 months until next milestone

Study Start

First participant enrolled

June 25, 2024

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

2.4 years

First QC Date

February 26, 2024

Last Update Submit

March 24, 2025

Conditions

Anesthesia Hypercapnia Hypocapnia

Outcome Measures

Primary Outcomes (1)

To determine the effect of end-tidal carbon dioxide concentration (EtCO2) on the depth of anesthesia in children, as measured by BIS.
The investigator's study aims to determine whether differing levels of CO2 affect the anesthetic depth in anesthetized children, as measured by BIS. The investigators will determine a significant change in BIS to be at least a 5 point difference. Patients will act 'as their own controls', and be tested across three ETCO2 levels in a randomized order.
Continually assessed throughout the general anesthetic, approximately 1.5-2 hours

Secondary Outcomes (1)

Patient movement as detected clinically by the surgical or anesthetic team.
Continually assessed throughout the general anesthetic, approximately 1.5-2 hours