Bispectral Index to Guide Intubation in Pediatric Anesthesia

NCT ID: NCT02806596

Last Updated: 2016-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-06-30

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)

Conditions

Anesthesia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

sevoflurane

• 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

Group Type: OTHER

Sevoflurane

Intervention Type: 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).

Interventions

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).

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Liege

OTHER

Sponsor Role: lead

Responsible Party

Claude Hallet

Chief of Clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

BIS02ch

Identifier Type: -

Identifier Source: org_study_id