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

This study is currently recruiting participants.

Verified by University Hospital, Ghent, April 2009

First Received: April 14, 2006 Last Updated: April 9, 2009 History of Changes

Sponsor:	University Hospital, Ghent
Information provided by:	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:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
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
Blood pressure

Estimated Enrollment:	80
Study Start Date:	May 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

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

Contacts

Contact: Koen Reyntjens, MD

+ 32 9 332.49.55

k.reyntjens@UGent.be

Locations

Belgium
University Hospital Ghent	Recruiting
Ghent, Belgium, 9000
Contact: Koen Reyntjens, MD + 32 9 332.49.55 k.reyntjens@UGent.be
Principal Investigator: Koen Reyntjens, MD

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 ( Koen Reyntjens )
Study ID Numbers:	2006/042
Study First Received:	April 14, 2006
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00315536 History of Changes
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Remifentanil
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Cholinergic Agents
Pharmacologic Actions
Adjuvants, Anesthesia

Muscarinic Antagonists
Anesthetics, General
Sensory System Agents
Glycopyrrolate
Therapeutic Uses
Hypnotics and Sedatives
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 27, 2009