- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01427985
Influence of Premedication Protocols for Neonatal Endotracheal Intubation on Cerebral Oxygenation
April 5, 2016 updated by: Manuel Schmid, University of Ulm
The Influence of Two Different Premedication Protocols for Endotracheal Intubation in Neonates on Cerebral Oxygenation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 .
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Baden-Württemberg
-
Ulm, Baden-Württemberg, Germany, 89075
- University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 10 months (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- newborn infant below 44 weeks postmenstrual age
- indication for elective or semi-elective endotracheal Intubation
- parental informed consent
Exclusion Criteria:
- emergency intubation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Relaxation followed by analgosedation
Give Atropin, then Mivacurium, immediately followed by Fentanyl
|
|
ACTIVE_COMPARATOR: Analgosedation followed by Relaxation
Give atropin, then Fentanyl, then Mivacurium
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
from 1 minute before first study drug until 10 minutes after end of procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (ACTUAL)
July 1, 2012
Study Completion (ACTUAL)
July 1, 2012
Study Registration Dates
First Submitted
August 31, 2011
First Submitted That Met QC Criteria
September 1, 2011
First Posted (ESTIMATE)
September 2, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
April 6, 2016
Last Update Submitted That Met QC Criteria
April 5, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Neuromuscular Agents
- Mydriatics
- Neuromuscular Nondepolarizing Agents
- Neuromuscular Blocking Agents
- Fentanyl
- Atropine
- Mivacurium
Other Study ID Numbers
- ULMNEONIRS02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intubation
-
Spanish Network for Research in Infectious DiseasesCompletedIntubation | Intubation Complication | Intubation; Difficult or FailedSpain
-
University Hospital, Clermont-FerrandSociété Française d'Anesthésie-Réanimation (SFAR)Not yet recruitingEndotracheal Intubation | Intubation Complication | Intubation; Difficult or Failed
-
Emory UniversityTerminatedAirway Morbidity | Intubation Complication | Anesthesia Intubation Complication | Tracheal Intubation Morbidity | Failed or Difficult Intubation, SequelaUnited States
-
Catharina Ziekenhuis EindhovenCompletedAnesthesia Intubation Complication | Intubation; Difficult | Failed or Difficult Intubation | Failed or Difficult Intubation, Initial EncounterNetherlands
-
Children's Hospital of PhiladelphiaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedIntubation Complication | Intubation;Difficult | Failed or Difficult Intubation, SequelaUnited States, Canada, Singapore
-
Children's Hospital of PhiladelphiaAgency for Healthcare Research and Quality (AHRQ)RecruitingIntubation Complication | Intubation; Difficult | Failed or Difficult Intubation, SequelaUnited States, Canada, Japan, Italy, New Zealand, Singapore, Australia, Austria, Germany, India, United Kingdom
-
Kaohsiung Medical University Chung-Ho Memorial...CompletedIntubation, Nasotracheal IntubationTaiwan
-
University Hospital HeidelbergRecruitingIntubation | Intubation ComplicationGermany
-
Kaohsiung Medical University Chung-Ho Memorial...CompletedIntubation Complication | Intubation, DifficultTaiwan
-
Huazhong University of Science and TechnologyCompletedIntubation Complication | Intubation; DifficultChina
Clinical Trials on Atropine, Fentanyl, Mivacurium
-
Tang-Du HospitalJiangsu Nhwa Pharmaceutical Co., Ltd.UnknownLiver DysfunctionChina
-
Al-Azhar UniversityRecruiting
-
University of Texas Southwestern Medical CenterChiesi Farmaceutici S.p.A.RecruitingRespiratory Distress Syndrome, NewbornUnited States
-
Washington University School of MedicineAmerican Diabetes AssociationCompletedPre-diabetesUnited States
-
King Saud UniversityMcMaster UniversityCompleted
-
Assiut UniversityCompleted
-
University of California, San FranciscoOslo University HospitalCompletedMuscle Relaxation | SexUnited States
-
China Medical University, ChinaCompleted
-
Leiden University Medical CenterCompletedRenal Disease | Prostate HypertrophyNetherlands