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Remifentanil Minimum Effective Dose for Children Intubation Without Neuromuscular Blockade

Remifentanil Minimum Effective Dose for Children Intubation Without Neuromuscular Blockade

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02454868
Enrollment
30
Registered
2015-05-27
Start date
2016-07-31
Completion date
2016-07-31
Last updated
2016-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Underdosing of Unspecified General Anesthetics

Keywords

Remifentanil, Intubation, Children

Brief 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.

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.

Interventions

DRUGRemifentanil

Remifentanil for intubation without neuromuscular blockade

Sponsors

University of Brasilia
CollaboratorOTHER
Brasilia University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 9 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Adequate intubation condition (dichotomic) as an assessment of success rateintraoperativeIntubation 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026