Anesthesia, Laryngospasm on Emergence
Conditions
Keywords
Pediatric, Anesthesia, Extubation, Pupillometry
Brief summary
Investigation of pupillometry as guide for extubation readiness in anesthetized children.
Detailed description
Can a pupil metric be used to make extubation more safe in anesthetized children?
Interventions
DIAGNOSTIC_TESTPupillometry
Pupillometry prior to extubation
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* Children undergoing general anesthesia and endotracheal intubation for surgery. * American Society of Anesthesiologists Physical Status Class I and II patients.
Exclusion criteria
* Central nervous system abnormality. * Ophthalmologic abnormality.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extubation Success | Immediately after extubation | Maintenance of spontaneous ventilation without pathologic airway response such as laryngospasm. Ventilation monitored in a standard manner, using chest wall movement, capnography, reservoir bag movement, condensation of anesthetic mask and auscultation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anesthetic Vapor Concentration at Extubation | At the time of extubation | Percent of end-tidal sevoflurane at extubation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Breath-holding | Prior to extubation | Measurement tool: Capnogram |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Traditional deep extubation at 1.5 minimum alveolar concentration (MAC) | 10 |
| Group 2 Deep extubation guided by pupillometry -- at \< 0.5 MAC of vapor + propofol and fentanyl
Pupillometry: Pupillometry prior to extubation | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Group 2 | Total | Group 1 |
|---|---|---|---|
| Age, Continuous | 5.5 years STANDARD_DEVIATION 3.2 | 5.0 years STANDARD_DEVIATION 3 | 4.4 years STANDARD_DEVIATION 2.9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Extubation Success
Maintenance of spontaneous ventilation without pathologic airway response such as laryngospasm. Ventilation monitored in a standard manner, using chest wall movement, capnography, reservoir bag movement, condensation of anesthetic mask and auscultation.
Time frame: Immediately after extubation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 | Extubation Success | 10 Participants |
| Group 2 | Extubation Success | 10 Participants |
Secondary
Anesthetic Vapor Concentration at Extubation
Percent of end-tidal sevoflurane at extubation
Time frame: At the time of extubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Anesthetic Vapor Concentration at Extubation | 3.8 Percent of sevoflurane | Standard Deviation 0 |
| Group 2 | Anesthetic Vapor Concentration at Extubation | 0.8 Percent of sevoflurane | Standard Deviation 0.1 |
Other Pre-specified
Breath-holding
Measurement tool: Capnogram
Time frame: Prior to extubation