Remifentanil Minimum Effective Dose for Children Intubation Without Neuromuscular Blockade
Information source: Brasilia University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Underdosing of Unspecified General Anesthetics
Intervention: Remifentanil (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Brasilia University Hospital Official(s) and/or principal investigator(s):
Catia S Goveia, MSc, Principal Investigator, Affiliation: University of Brasilia
Overall contact:
Gabriel MN Guimaraes, MSc, Phone: +556196455997, Email: gabriel@gabriel.med.br
Summary
Introduction: remifentanil's optimal dose for children intubation without neuromuscular
blockade is unknown. Method: phase IV adaptative trial using Dixon's up-and-down method for
modeling remifentanil's dose-response curve for adequate intubation conditions as defined by
previous studies.
Clinical Details
Official title: Remifentanil Minimum Effective Dose for Children Intubation Without Neuromuscular Blockade
Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
Primary outcome: Incidence of Adequate intubation condition (dichotomic) as an assessment of success rate
Detailed description:
Introduction: remifentanil's optimal dose for children intubation without neuromuscular
blockade is unknown.
Method: phase IV adaptative trial using Dixon's up-and-down method for modeling
remifentanil's dose-response curve for adequate intubation conditions as defined by previous
studies. Remifentanil doses starting from 2mg/kg will be infused before intubation. When a
success occurs next patient's dose will be decreased by 0. 25mg/kg/h. When a success does not
occur the next patient's dose will be increased by 0. 25mg/kg/h. Intubation will be
considered adequate if patient does not cough, does not move, if vocal cords are open, if
larigocsocpic Cormack grade I or II.
Eligibility
Minimum age: 2 Years.
Maximum age: 9 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- ASA I or II
- Scheduled for surgery under general anesthesia.
Exclusion Criteria:
- Predicted difficult airway
- Severe neurologic or cardiologic conditions
- Recent upper airway infectious diseases
Locations and Contacts
Gabriel MN Guimaraes, MSc, Phone: +556196455997, Email: gabriel@gabriel.med.br Additional Information
Starting date: May 2015
Last updated: May 26, 2015
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