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Echocardiographic Study of the Haemodynamic Effects of Remifentanil With and Without Glycopyrrolate in Healthy Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00315536
Recruitment Status : Completed
First Posted : April 18, 2006
Last Update Posted : January 5, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Study Description
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Brief Summary:
Study to investigate the influence of remifentanil and glycopyrrolate on cardiac index and blood pressure in children.To differentiate between contractility and the effect of the circulating volume, some of the subjects will receive additional fluid.This will be evaluated using two transthoracic echocardiac exams within the first 30 min of anesthesia.

Condition or disease Intervention/treatment Phase
Urological Surgery Drug: Administration of remifentanil and glycopyrrolate Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Echocardiographic Study of the Haemodynamic Effects of Remifentanil With and Without Glycopyrrolate in Healthy Children
Study Start Date : May 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

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Arms and Interventions
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Intervention Details:
  • Drug: Administration of remifentanil and glycopyrrolate
    2 mg, intravenius use

Outcome Measures
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Primary Outcome Measures :
  1. Cardiac index [ Time Frame: Twice in 16 minutes. ]
  2. Blood pressure [ Time Frame: Twice in 16 minutes. ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA I and II children
  • 1-6 years
  • urological surgery

Exclusion Criteria:

  • Cardiac disease
  • Diabetes
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315536


Locations
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Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Koen Reyntjens, MD University Hospital, Ghent
More Information
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Additional Information:

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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00315536    
Other Study ID Numbers: 2006/042
First Posted: April 18, 2006    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Glycopyrrolate
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action