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Bispectral Index to Guide Intubation in Pediatric Anesthesia

Use of Bispectral Index to Guide Intubation During Sevoflurane Anesthesia in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02806596
Enrollment
60
Registered
2016-06-20
Start date
2010-01-31
Completion date
2013-06-30
Last updated
2016-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief summary

This prospective study aimed to determine the minimal level of Bispectral index needed for quality laryngoscopy before ear, nose and throat surgery in children.

Detailed description

* Children will received intra-rectal premedication based on midazolam 0.4mg * Children will be monitored according to standard guidelines * One blinded anesthesiologist will be in charge of anesthesia induction and the other one will be in charge of data collection (end tidal sevoflurane concentration, sevoflurane minimal alveolar concentration, bispectral index) and guidance of induction according to the predetermined bispectral index (up and down allocation)

Interventions

DRUGSevoflurane

After at least 4 minutes of stable inspired sevoflurane concentration, that concentration will be titrated to obtain a targeted bispectral index (BIS) level required for perform laryngoscopy. This level was initially set at 40, based on a preliminary study showing that such level of BIS was obtained at the laryngoscopy after common general anesthesia induction. For the next patients, BIS target was set according to a sequential allocation method (up and down).

Sponsors

University of Liege
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
Yes

Inclusion criteria

* American Society Anesthesiology physical status classification system :1 or 2 * scheduled ear, nose and throat surgery in a one day program * oral intubation required

Exclusion criteria

* parents refusal * recent respiratory infection * epilepsy * suspected difficult intubation

Design outcomes

Primary

MeasureTime frameDescription
laryngeal conditions of intubation5 minutesspecific conditions will be assessed and scored : jaw relaxation, vocal cord position, cough at intubation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026