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Remifentanil and Atropine for Intubation in Neonates (RAIN)

This study has been completed.
Sponsor:
Collaborator:
McMaster University
Information provided by:
King Saud University
ClinicalTrials.gov Identifier:
NCT00815048
First received: December 24, 2008
Last updated: December 26, 2008
Last verified: December 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Endotracheal Intubation
 Drug: Atropine/Remifentanil
Drug: Fentanyl/Atropine/Succinylcholine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Remifentanil and Atropine for Intubation in Neonates; a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by King Saud University:

Primary Outcome Measures:
  • Time to Successful intubation [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to return of spontaneous respirations [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
  • Oxygen saturation [ Time Frame: During the procedure up to 15 minutes ] [ Designated as safety issue: Yes ]
  • Heart Rate [ Time Frame: During the procedure up to 15 minutes ] [ Designated as safety issue: Yes ]
  • Blood Pressure [ Time Frame: During the procedure up to 15 minutes ] [ Designated as safety issue: Yes ]
  • Intubation Condition [ Time Frame: 15 minutes post procedure ] [ Designated as safety issue: No ]
  • Evidence of Trauma [ Time Frame: 15 minutes post procedure ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: January 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Remifentanil

Atropine

Remifentanil

 Drug: Atropine/Remifentanil

Atropine 20mcg/kg

Remifentanil 3mcg/kg
Placebo Comparator: Fentanyl

Atropine

Fentanyl

Succinylcholine

 Drug: Fentanyl/Atropine/Succinylcholine

Atropine 20mcg/kg

Fentanyl 2mcg/kg

Succinylcholine 2mg/kg

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815048

Locations
Canada, Ontario
McMaster University NICU
Hamilton, Ontario, Canada, L8S 4J9
Sponsors and Collaborators
King Saud University
McMaster University
Investigators
Principal Investigator: Khalid M Alfaleh, MBBS, MSc King Saud University
Study Director: Karen Choong, FRCPC McMaster University
  More Information

No publications provided

Responsible Party: Khalid AlFaleh, King Saud University
ClinicalTrials.gov Identifier: NCT00815048     History of Changes
Other Study ID Numbers: RAIN
Study First Received: December 24, 2008
Last Updated: December 26, 2008
Health Authority: Canada: Health Canada

Keywords provided by King Saud University:
Remifentanil
Endotracheal intubation
Premedication
Sedation
Endotracheal Intubation in Neonates

Additional relevant MeSH terms:
Atropine
Fentanyl
Remifentanil
Succinylcholine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
 Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on June 17, 2013