NCT02454868

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

Same day

First QC Date

May 14, 2015

Last Update Submit

July 18, 2016

Conditions

Underdosing of Unspecified General Anesthetics

Keywords

RemifentanilIntubationChildren

Outcome Measures

Primary Outcomes (1)

  • 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

    intraoperative

Study Arms (1)

Study arm

EXPERIMENTAL

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

Interventions

RemifentanilDRUG

Remifentanil for intubation without neuromuscular blockade

Also known as: Ultiva
Study arm

Eligibility Criteria

Age2 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • ASA I or II
  • Scheduled for surgery under general anesthesia.

You may not qualify if:

  • Predicted difficult airway
  • Severe neurologic or cardiologic conditions
  • Recent upper airway infectious diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ono AH, Moura TR, Goveia CS, Guimaraes GMN, de Araujo Ladeira LC, da Silva HBG. ED50 of remifentanil for providing excellent intubating conditions when co-administered with a single standard dose of propofol without the use of muscle relaxants in children: dose-finding clinical trial. J Anesth. 2018 Aug;32(4):493-498. doi: 10.1007/s00540-018-2502-z. Epub 2018 May 4.

    PMID: 29728755DERIVED

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Catia S Goveia, MSc

    University of Brasilia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

May 14, 2015

First Posted

May 27, 2015

Study Start

July 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 19, 2016

Record last verified: 2016-07