Remifentanil and Atropine for Intubation in Neonates | NCT00815048

Studies
Remifentanil and Atropine for Intubation in Neonates

NCT00815048

Sponsor

King Saud University

Status

Completed

Last Update Posted

Dec 29, 2008Estimated

Enrollment

30Actual

Phase

Phase 4

Conditions

Endotracheal Intubation

Interventions

Atropine/Remifentanil
Fentanyl/Atropine/Succinylcholine

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Feb 2008Actual

Completion Date

Feb 2008Actual

First Submitted Date

Dec 24, 2008

First Submission Date that Met QC Criteria

Dec 26, 2008

First Posted Date

Dec 29, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2008

Last Update Posted Date

Dec 29, 2008Estimated

Name	Class
McMaster University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Remifentanil	Active Comparator	Atropine Remifentanil	Drug: Atropine/Remifentanil
Fentanyl	Placebo Comparator	Atropine Fentanyl Succinylcholine	Drug: Fentanyl/Atropine/Succinylcholine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atropine/Remifentanil	Drug	Atropine 20mcg/kg Remifentanil 3mcg/kg	Remifentanil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Successful intubation		15 minutes

Secondary Outcomes

Measure	Description	Time Frame
Time to return of spontaneous respirations		15 minutes
Oxygen saturation		During the procedure up to 15 minutes
Heart Rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Khalid M Alfaleh, MBBS, MSc	King Saud University	Principal Investigator
Karen Choong, FRCPC	McMaster University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McMaster University NICU		Hamilton	Ontario	L8S 4J9	Canada

Intervention Browse Module

MeSH Terms

ID	Term
D001285	Atropine
D000077208	Remifentanil
D005283	Fentanyl

Ancestor Terms

ID	Term
D001286	Atropine Derivatives
D014326	Tropanes
D053961	Azabicyclo Compounds
D001372	Aza Compounds

Browse Leaves

Not provided

Browse Branches

Not provided