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

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Ghent Identifier:
First received: April 14, 2006
Last updated: January 3, 2012
Last verified: January 2012
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 Intervention Phase
Urological Surgery
Drug: Administration of remifentanil and glycopyrrolate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Echocardiographic Study of the Haemodynamic Effects of Remifentanil With and Without Glycopyrrolate in Healthy Children

Resource links provided by NLM:

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Cardiac index [ Time Frame: Twice in 16 minutes. ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Twice in 16 minutes. ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: May 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Administration of remifentanil and glycopyrrolate
    2 mg, intravenius use

Ages Eligible for Study:   1 Year to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Cardiac disease
  • Diabetes
  Contacts and Locations
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Please refer to this study by its identifier: NCT00315536

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

Additional Information:
Responsible Party: University Hospital, Ghent Identifier: NCT00315536     History of Changes
Other Study ID Numbers: 2006/042 
Study First Received: April 14, 2006
Last Updated: January 3, 2012
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Depressants
Cholinergic Agents
Cholinergic Antagonists
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 24, 2016