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

Urological Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315536
• Other study ID #: 2006/042
• Status: Completed
• Phase: Phase 2
• First received: April 14, 2006
• Last updated: January 3, 2012
• Start date: May 2006
• Est. completion date: April 2009

Study information

• Verified date: January 2012
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 6 Years

Eligibility

Inclusion Criteria:

• ASA I and II children

• 1-6 years

• urological surgery

Exclusion Criteria:

• Cardiac disease

• Diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urological Surgery

Intervention

Drug:
• Administration of remifentanil and glycopyrrolate
2 mg, intravenius use

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac index		Twice in 16 minutes.	No
Primary	Blood pressure		Twice in 16 minutes.	No

External Links

•   Website of the University Hospital Ghent