Bispectral Index to Guide Intubation in Pediatric Anesthesia

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

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Key information

Conditions

Anesthesia

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane

Drug

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).

Primary outcomes

laryngeal conditions of intubation

Time frame: 5 minutes

specific conditions will be assessed and scored : jaw relaxation, vocal cord position, cough at intubation

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Jun 20, 2016
Registry last updated: Jun 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed