A Phase 4 interventional study of Remifentanil in Underdosing of Unspecified General Anesthetics, sponsored by Brasilia University Hospital. Completed. Open to participants aged 2 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-19.
Sponsored by Brasilia University Hospital · Phase 4, Interventional, and Supportive care
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.
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.
Brasilia University Hospital is the lead sponsor of 20 studies on the registry; none are open to participants now.
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There is a single study arm. Remifentanil will be infused before intubation. The first patient will receive remifentanil 2mg/kg. If a success occurs the next patient's dose will be decreased by 0.25mg/kg and else it will be increased by 0.25mg/kg. This rule will apply recursively as Dixon's Up-And-Down Method.
Drug: Remifentanil
Remifentanil for intubation without neuromuscular blockade
Also known as: Ultiva
Incidence of Adequate intubation condition (dichotomic) as an assessment of success rate
Intubation is adequate if patient does not cough, does not try to breathe, vocal cords do not move, patient does not react and laringoscopy is Cormack class I or II
Time frame: intraoperative
No study locations are listed for this record.
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Brasilia University Hospital