Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet
Cisatracurium
+ Normal saline
Treatment Study
Summary
Study start date: January 1, 2007
Actual date on which the first participant was enrolled.The investigators' primary specific aims are to demonstrate that: 1. 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. 2. 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.34 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 6 Months to 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location