Bispectral Index to Guide Intubation in Pediatric Anesthesia

NCT02806596 | Completed DMC

• 1 other identifier: BIS02ch
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• laryngeal conditions of intubation

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

  5 minutes

Study Arms (1)

sevoflurane

OTHER

* induction of anesthesia using sevoflurane administered with facial mask at inspired concentration of 6% (in a mixture of oxygen and nitrous oxyde) * intervention : titration of inspired sevoflurane concentration until targeted bispectral index

Drug: Sevoflurane

Interventions

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).

sevoflurane

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Liege: lead

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Clinic

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 20, 2016
• Study Start: January 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 29, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share