Remifentanil Minimum Effective Dose for Children Intubation Without Neuromuscular Blockade

Phase 4

Completed

• Conditions: Underdosing of Unspecified General Anesthetics
• Interventions: Drug: Remifentanil

• Registration Number: NCT02454868
• Lead Sponsor: Brasilia University Hospital

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.

Study Timeline

• Study First Submitted: 2015-05-14
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-27
• Status Verified: 2016-07
• Study Start: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-18
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study arm	Remifentanil	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Adequate intubation condition (dichotomic) as an assessment of success rate	intraoperative	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