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

Tracking Information

First Received Date ^ICMJE

April 14, 2006

Last Updated Date

April 9, 2009

Start Date ^ICMJE

May 2006

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cardiac index
Blood pressure

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00315536 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Urological Surgery

Intervention ^ICMJE

Drug: Administration of remifentanil and glycopyrrolate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

ASA I and II children
1-6 years
urological surgery

Exclusion Criteria:

Cardiac disease
Diabetes

Gender

Both

Ages

1 Year to 6 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Koen Reyntjens, MD

+ 32 9 332.49.55

k.reyntjens@UGent.be

Location Countries ^ICMJE

Belgium

Administrative Information

NCT ID ^ICMJE

NCT00315536

Responsible Party

Koen Reyntjens, University Hospital Ghent

Study ID Numbers ^ICMJE

2006/042

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Koen Reyntjens, MD

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP