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Remifentanil and Atropine for Intubation in Neonates

NCT ID: NCT00815048

Last Updated: 2008-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-02-29

Brief Summary

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The investigators hypothesize that the use of a combination of Atropine and Remifentanil will safely facilitate non emergent intubation procedure as effectively as the protocol of Atropine, Fentanyl, and Succinylcholine.

Detailed Description

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Conditions

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Endotracheal Intubation

Keywords

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Remifentanil Endotracheal intubation Premedication Sedation Endotracheal Intubation in Neonates

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Remifentanil

Atropine

Remifentanil

Group Type ACTIVE_COMPARATOR

Atropine/Remifentanil

Intervention Type DRUG

Atropine 20mcg/kg

Remifentanil 3mcg/kg

Fentanyl

Atropine

Fentanyl

Succinylcholine

Group Type PLACEBO_COMPARATOR

Fentanyl/Atropine/Succinylcholine

Intervention Type DRUG

Atropine 20mcg/kg

Fentanyl 2mcg/kg

Succinylcholine 2mg/kg

Interventions

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Atropine/Remifentanil

Atropine 20mcg/kg

Remifentanil 3mcg/kg

Intervention Type DRUG

Fentanyl/Atropine/Succinylcholine

Atropine 20mcg/kg

Fentanyl 2mcg/kg

Succinylcholine 2mg/kg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hemodynamically stable neonates of any gestational age admitted to the Neonatal Intensive Care Unit at McMaster Children's Hospital requiring an elective endotracheal intubation was anticipated.

Exclusion Criteria

* Urgent intubations
* Cyanotic congenital heart lesions
* Anticipated difficult airway
* Concurrent or recently administered (within 3 hours of the procedure) intravenous opioid infusions
* Pre-existing hyperkalemia
* Family history of malignant hyperthermia
* Prior enrollment
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role collaborator

King Saud University

OTHER

Sponsor Role lead

Responsible Party

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King Saud University

Principal Investigators

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Khalid M Alfaleh, MBBS, MSc

Role: PRINCIPAL_INVESTIGATOR

King Saud University

Karen Choong, FRCPC

Role: STUDY_DIRECTOR

McMaster University

Locations

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McMaster University NICU

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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RAIN

Identifier Type: -

Identifier Source: org_study_id