Remifentanil Minimum Effective Dose for Children Intubation Without Neuromuscular Blockade

NCT ID: NCT02454868

Last Updated: 2016-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2016-07-31

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.

Conditions

Underdosing of Unspecified General Anesthetics

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Study arm

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.

Group Type: EXPERIMENTAL

Remifentanil

Intervention Type: DRUG

Remifentanil for intubation without neuromuscular blockade

Interventions

Remifentanil

Remifentanil for intubation without neuromuscular blockade

Intervention Type: DRUG

Other Intervention Names

Ultiva

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Brasilia

OTHER

Sponsor Role: collaborator

Brasilia University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gabriel Magalhaes Nunes Guimaraes

MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catia S Goveia, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Brasilia

References

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.

Reference Type: DERIVED

PMID: 29728755 (View on PubMed)

Other Identifiers

UBrasilia

Identifier Type: -

Identifier Source: org_study_id