Determination of the Amount of Propofol Needed to Supplement 5% Sevoflurane for Intubation of Children Without Neuromuscular Blockade

This study has been completed.
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT01150838
First received: June 2, 2010
Last updated: August 9, 2011
Last verified: August 2011
  Purpose

The purpose of this study is to determine the least amount of propofol that is needed to place a breathing tube in children 1-12 years old.


Condition Intervention Phase
Anesthesia Intubation Complication
Drug: propofol
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Determination of the Amount of Propofol Needed to Supplement 5% Sevoflurane for Intubation of Children Without Neuromuscular Blockade,IRB-HSR# 13666

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Intubation condition score [ Time Frame: 1 minute following administration of propofol ] [ Designated as safety issue: Yes ]
    The quality of tracheal intubation will be graded according to the ease of laryngoscopy, position of the vocal cords, coughing, jaw relaxation and movement of limbs. The intubation conditions will be classified as either excellent or not excellent. "Excellent" (1) will be defined as the best possible score in all 5 scoring categories, and "not excellent" (2-4) will be anything less.


Estimated Enrollment: 150
Study Start Date: July 2008
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Propofol administration
Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent". Dose will be decreased by 0.3 mg/kg if intubation score is "excellent". This dosing scheme will be continued.
Drug: propofol
Initial dose: Propofol 2 mg/kg, then dose changes separately based on the last subject in the same age group and sevo time range
Other Name: propofol

Detailed Description:

The practice of tracheal intubation of children without neuromuscular blockade (TIWNB) is widespread in pediatric anesthesia practices. There are several different methods reported for TIWNB, most of which involve administration of an inhaled anesthetic in combination with another medication. The technique of administering propofol IV, immediately after IV placement, after a sevoflurane induction is a popular methods for pediatric TIWNB in the United States and worldwide (personal communication, and personal practice of this technique). To date, nobody has studied this technique, and therefore nobody has quantified the amount of propofol needed in this context.

The practice of tracheal intubation of children without neuromuscular blockade (TIWNB) is widespread in pediatric anesthesia practices. There are several different methods reported for TIWNB, most of which involve administration of an inhaled anesthetic in combination with another medication. The technique of administering propofol IV, immediately after IV placement, after a sevoflurane induction is a popular methods for pediatric TIWNB in the United States and worldwide (personal communication, and personal practice of this technique). To date, nobody has studied this technique, and therefore nobody has quantified the amount of propofol needed in this context.

  Eligibility

Ages Eligible for Study:   1 Year to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150838

Locations
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22911
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: George D Politis, MD UVA Department of Anesthesiology
  More Information

Publications:
Dixon WJ. Quantal response to variable experimentation: the up-and-down method. In: McArthur JW, Colton T, eds. Statistics in Endocrionolgy. Cambridge: MIT Press, 1967: 251-264.

Responsible Party: George D. Politis, M.D., University of Virginia Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT01150838     History of Changes
Other Study ID Numbers: 13666
Study First Received: June 2, 2010
Last Updated: August 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
intubation of children without neuromuscular blockade

Additional relevant MeSH terms:
Propofol
Sevoflurane
Anesthetics
Anesthetics, General
Anesthetics, Inhalation
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hematologic Agents
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014