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Completed

NCT Number: NCT02454868

Remifentanil Minimum Effective Dose for Children Intubation Without Neuromuscular Blockade

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.

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Key information

Conditions

Underdosing of Unspecified General Anesthetics

Age range

2 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

Remifentanil for intubation without neuromuscular blockade

Other names: Ultiva

Primary outcomes

  1. Incidence of Adequate intubation condition (dichotomic) as an assessment of success rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Brasilia University Hospital

Other

Collaborators

  • University of Brasilia

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 27, 2015
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.