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Echocardiographic study of the haemodynamic effects of remifentanil with and without glycopyrrolate in healthy childre

Conditions
ASA I and II children
Registration Number
EUCTR2006-000460-90-BE
Lead Sponsor
niversity Hospital Ghent
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
80
Inclusion Criteria

ASA I and II male and female patients, aged 1-6 years, scheduled for urological surgery
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

children with cardiac disease and diabetes

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: Remifentanil is a short acting mu opioid agonist used in general anaesthesia. Its use induces bradycardia and possibly hypotension. By associating glycopyrrolate, these side effects can be countered. This study evaluates the haemodynamic effects of this combination in healthy children by means of transthoracic echocardiography in order to determine the influence of preload, afterload and cardiac contractility.;Secondary Objective: ;Primary end point(s): Measure the effect of glycopyrrolate and remifentanil on cardiac contractility, preload and afterload, and blood pressure.
Secondary Outcome Measures
NameTimeMethod
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