Bispectral Index to Guide Intubation in Pediatric Anesthesia

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02806596
• Other study ID #: BIS02ch
• Status: Completed
• Phase: N/A
• First received: June 8, 2016
• Last updated: June 28, 2016
• Start date: January 2010
• Est. completion date: June 2013

Study information

• Verified date: June 2016
• Source: University Hospital of Liege
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 8 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Sevoflurane
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	laryngeal conditions of intubation	specific conditions will be assessed and scored : jaw relaxation, vocal cord position, cough at intubation	5 minutes	No