Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet

Study Overview
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Brief Summary
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The investigators' primary specific aims are to demonstrate that: Pediatric patients with normal airways, undergoing elective surgical procedures, can be successfully intubated when deeply sedated, without the use of muscle relaxants using the Shikani Optical Stylet. Shikani intubation of pediatric patients is equally effective in children that are deeply sedated or paralyzed as evidenced by a non-significant difference in: Time to intubation (defined as no more than a 30 second time difference between the two groups); Incidence of adverse events.

Official Title
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Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet

Conditions
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Intubation,Endotracheal

Intervention / Treatment
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* Drug: Cisatracurium
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6 months of age to 17 years of age (not yet 18) Male or female English or Spanish speaking Normal airway (Mallampati Classification ) American Society of Anesthesiology Physical Status Classification I or II Elective surgical procedure expected to last at least 45 minutes in length Written informed consent/assent for participation given by the parent legal guardian and subject (if applicable) Exclusion Criteria: < 6 months of age, > 17 years of age Difficult airway (Mallampati Classification) History of previous difficult intubation, suspected abnormal airway: *micrognathia facial trauma airway tumor epiglottitis retropharyngeal abscess foreign body, etc. Scheduled for non-elective, emergent OR procedure Parent, legal guardian, or subject is unavailable or unwilling to consent for study participation

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal saline<br>Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg | Drug: Normal saline<br>* One Intravenous dose<br>|
| Active Comparator: Cisatracurium<br>Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation. | Drug: Cisatracurium<br>* One intravenous dose: 0.2mg/kg/dose<br>* Other names: Nimbex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Intubation | Time to intubation was defined as the time (seconds) required to verify three breaths on an end-tidal carbon dioxide monitor. | Confirmed by the visualization of three carbon dioxide waveforms. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Adverse Events | The number of occurrences of each event. One subject may have multiple adverse events. | Recorded from the start of the intubation procedure to the time of successful endotracheal intubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric