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Clinical Trials/NCT02806596
NCT02806596CompletedNot Applicable

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

University of Liege0 sites60 target enrollmentStarted: January 2010Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Primary Endpoint
laryngeal conditions of intubation
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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)

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Masking
None

Eligibility Criteria

Ages
2 Years to 8 Years (Child)
Sex
All
Accepts 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
  • •suspected difficult intubation

Arms & Interventions

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

Intervention: Sevoflurane (Drug)

Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Claude Hallet

Chief of Clinic

University of Liege

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