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

This study has been completed.

First Received on April 14, 2006. Last Updated on January 3, 2012 History of Changes

Sponsor:	University Hospital, Ghent
Information provided by (Responsible Party):	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00315536

Purpose

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 II

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:

Drug Information available for: Remifentanil hydrochloride Remifentanil Glycopyrrolate

U.S. FDA Resources

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:

2 mg, intravenius use

Eligibility

Ages Eligible for Study:	1 Year to 6 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315536

Locations

Belgium
University Hospital Ghent
Ghent, Belgium, 9000

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator:

Koen Reyntjens, MD

University Hospital, Ghent

More Information

Additional Information:

Website of the University Hospital Ghent This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University Hospital, Ghent
ClinicalTrials.gov 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: Directorate general for the protection of Public health: Medicines

Additional relevant MeSH terms:

Glycopyrrolate
Remifentanil
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on February 09, 2012