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Influence of Premedication Protocols for Neonatal Endotracheal Intubation on Cerebral Oxygenation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Manuel Schmid, University of Ulm
ClinicalTrials.gov Identifier:
NCT01427985
First received: August 31, 2011
Last updated: April 5, 2016
Last verified: April 2016
  Purpose
The purpose of this study is to examine the influence of premedication drugs Atropin, Fentanyl and Mivacurium and of endotracheal intubation on cerebral oxygenation and cardiac output in term and preterm newborn infants. Two different protocols of premedication are compared.

Condition Intervention Phase
Newborn
Preterm
Intubation
Drug: Atropine, Fentanyl, Mivacurium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Influence of Two Different Premedication Protocols for Endotracheal Intubation in Neonates on Cerebral Oxygenation

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Change of cerebral tissue oxygen saturation during premedication and intubation [ Time Frame: from 1 minute before first study drug until 10 minutes after end of procedure ] [ Designated as safety issue: No ]
    A baseline value of cerebral tissue oxygen saturation before first application of premedication drugs is determined. Change of cerebral tissue oxygen saturation is defined as area under this threshold from first drug application until recovery.


Enrollment: 24
Study Start Date: June 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Relaxation followed by analgosedation
Give Atropin, then Mivacurium, immediately followed by Fentanyl
Drug: Atropine, Fentanyl, Mivacurium
  1. Atropin 10µg/kg
  2. Mivacurium 200µg/kg immediately followed by
  3. Fentanyl 2µg/kg
Active Comparator: Analgosedation followed by Relaxation
Give atropin, then Fentanyl, then Mivacurium
Drug: Atropine, Fentanyl, Mivacurium
  1. Atropin 10µg/kg
  2. Fentanyl 2µg/kg, repeat max. two times
  3. Mivacurium 200µg/kg

Detailed Description:

Influence of the following procedures will be examined:

  • Application of Atropin
  • Application of Fentanyl
  • Application of Mivacurium
  • possible desaturation and / or bradycardia during intubation attempts
  • restoration of arterial oxygen saturation and / or heart rate after succesful intubation

We aim to examine the change of the following parameters by the use of electrical cardiometry:

  • stroke volume
  • cardiac output

We compare two different premedication protocols and we evaluate the impact of these protocol on the time needed for intubation and on intubation difficulties .

  Eligibility

Ages Eligible for Study:   up to 44 Weeks   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • newborn infant below 44 weeks postmenstrual age
  • indication for elective or semi-elective endotracheal Intubation
  • parental informed consent

Exclusion Criteria:

  • emergency intubation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427985

Locations
Germany
University Medical Center
Ulm, Baden-Württemberg, Germany, 89075
Sponsors and Collaborators
University of Ulm
Investigators
Principal Investigator: Manuel B Schmid, Dr. med. University of Ulm
  More Information

Responsible Party: Manuel Schmid, Dr. med., University of Ulm
ClinicalTrials.gov Identifier: NCT01427985     History of Changes
Other Study ID Numbers: ULMNEONIRS02 
Study First Received: August 31, 2011
Last Updated: April 5, 2016
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Fentanyl
Atropine
Mivacurium
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 07, 2016