Phase 4 N=102 Health Services Research

Propofol for Pediatric Tracheal Intubation With Deep Anesthesia During Sevoflurane Induction

Anesthesia Intubation Complication

Bottom Line

View on ClinicalTrials.gov: NCT01150838 ↗

Enrolled (actual)

102

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Estimated Propofol Doses Producing 50% Excellent Intubation Conditions — 1.48; 0.00; 0.07; 2.35 mg/kg

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: propofol (Drug)
Age: Pediatric · 1+ yrs
Sex: All
Sponsor: University of Virginia
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Estimated Propofol Doses Producing 50% Excellent Intubation Conditions	1.48; 0.00; 0.07; 2.35; 2.33	—

Summary

The purpose of this study is to determine the amount of propofol required to achieve 50% of patients obtaining a perfect ("excellent") intubation score of 5 on the Steyn modification of the Helbo-Hansen Intubation Score, when placing a tracheal tube in children 1-6 years and 6-12 years (division of age groups at 6th birthday) of age, under a specific induction and ventilation sequence as specified in this study design.

Eligibility Criteria

Inclusion Criteria

Informed consent / assent
Ages 1-11 years (12 - 132 months)
American Society of Anesthesiology (ASA) physical status 1 or 2, which implies that the patient has no comorbidity that limits daily function.
Scheduled for non-emergent surgery/ procedure under general anesthesia in which the anesthesia team intends to place an endotracheal tube
Expected routine intubation according to physical exam and history
Weight under 50 kg

Exclusion Criteria

Requires neuromuscular blocking agents
Emergent surgery / procedure
Expected difficult intubation
ASA physical status 3 or 4
Weight over 50 kg
Age under 12 months or over 132 months
Allergy to study drugs to be used

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01150838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.