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

NCT00912990 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-08-18

Study results available
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Summary

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.

Conditions

  • Intubation,Endotracheal

Interventions

DRUG

Cisatracurium

One intravenous dose: 0.2mg/kg/dose

DRUG

Normal saline

One Intravenous dose

Sponsors & Collaborators

  • Rady Children's Hospital, San Diego

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00912990 on ClinicalTrials.gov