N/A
N=170
Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients
Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT04810481 ↗Enrolled (actual)
170
Serious AEs
0.8%
Results posted
Apr 2023
Primary outcome: Primary: End-tidal Sevoflurane Concentration — 2.1; 1.8; 2.5; 2.1 percent sevoflurane
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BIS Complete Monitoring System (Device)
- Age
- Pediatric, Adult · 4+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY End-tidal Sevoflurane Concentration |
2.1; 1.8; 2.5; 2.1; 2.2; 1.7 | — |
| SECONDARY Number of Participants With Each Score on the Wong Baker Faces Scale |
19; 5; 14; 18; 19; 17 | — |
| SECONDARY Modified Aldrete Score |
7.3; 8.1 | — |
| SECONDARY Number of Participants With Reported Airway Reflexes |
13; 4; 0; 0; 0; 0 | — |
| SECONDARY Clinical Anesthesia Assessment |
5; 5; 3; 3; 1; 0 | — |
Summary
The purpose of this study is to investigate the relationship between BIS™ values including EEG profile and anesthetic agents in the pediatric population
Eligibility Criteria
Inclusion Criteria
- Pediatric Subjects (ASA physical status I or II or III) aged: 4 years to 18 years scheduled for procedures with sedation where the process of assessment will not interfere with the procedure, progress, or patient care
Exclusion Criteria
- Has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes, or other medical sensors
- Known neurological disorder (e.g., epilepsy, the presence of a brain tumor, a history of brain surgery, hydrocephalic disorders, depression needing treatment with anti-depressive drugs, a history of brain trauma, hemiplegia, demyelinating disorders, cerebral palsy, congenital anomalies of the brain or spinal cord, or other known neurologic disorders)
- Severe developmental delay per assessment of investigator or report of parent/guardian
- Airway abnormalities
- Pregnancy; subjects of childbearing potential will have a urine screen for pregnancy before surgery
- If the process of assessment will interfere with the procedure or the progress of the procedure
- Taking psychoactive medications
- Taking any medications that may have an impact on the Central Nervous System (CNS)
- Planned use of any regional anesthesia; a local field block is not included in this exclusion and can be used at the discretion of the anesthesia provider
Data sourced from ClinicalTrials.gov (NCT04810481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.