NCT00815048

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.

Trial Health

87
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 Jan 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 29, 2008

Completed
Last Updated

December 29, 2008

Status Verified

December 1, 2008

Enrollment Period

2.1 years

First QC Date

December 24, 2008

Last Update Submit

December 26, 2008

Conditions

Endotracheal Intubation

Keywords

RemifentanilEndotracheal intubationPremedicationSedationEndotracheal Intubation in Neonates

Outcome Measures

Primary Outcomes (1)

  • Time to Successful intubation

    15 minutes

Secondary Outcomes (6)

  • Time to return of spontaneous respirations

    15 minutes

  • Oxygen saturation

    During the procedure up to 15 minutes

  • Heart Rate

    During the procedure up to 15 minutes

  • Blood Pressure

    During the procedure up to 15 minutes

  • Intubation Condition

    15 minutes post procedure

  • +1 more secondary outcomes

Study Arms (2)

Remifentanil

ACTIVE COMPARATOR

Atropine Remifentanil

Drug: Atropine/Remifentanil

Fentanyl

PLACEBO COMPARATOR

Atropine Fentanyl Succinylcholine

Drug: Fentanyl/Atropine/Succinylcholine

Interventions

Atropine/RemifentanilDRUG

Atropine 20mcg/kg Remifentanil 3mcg/kg

Remifentanil
Fentanyl/Atropine/SuccinylcholineDRUG

Atropine 20mcg/kg Fentanyl 2mcg/kg Succinylcholine 2mg/kg

Fentanyl

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University NICU

Hamilton, Ontario, L8S 4J9, Canada

Location

MeSH Terms

Interventions

AtropineRemifentanilFentanyl

Intervention Hierarchy (Ancestors)

Atropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Khalid M Alfaleh, MBBS, MSc

    King Saud University

    PRINCIPAL INVESTIGATOR

  • Karen Choong, FRCPC

    McMaster University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 24, 2008

First Posted

December 29, 2008

Study Start

January 1, 2006

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

December 29, 2008

Record last verified: 2008-12

Locations

CA(1)