Echocardiographic Study of the Haemodynamic Effects of Re... | NCT00315536

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

NCT00315536

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Jan 5, 2012Estimated

Enrollment

63Actual

Phase

Phase 2

Conditions

Urological Surgery

Interventions

Administration of remifentanil and glycopyrrolate

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Apr 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Apr 14, 2006

First Submission Date that Met QC Criteria

Apr 14, 2006

First Posted Date

Apr 18, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2012

Last Update Posted Date

Jan 5, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Administration of remifentanil and glycopyrrolate	Drug	2 mg, intravenius use

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiac index		Twice in 16 minutes.
Blood pressure		Twice in 16 minutes.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I and II children
1-6 years
urological surgery

Exclusion Criteria:

Cardiac disease
Diabetes

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Koen Reyntjens, MD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium

Label	URL
Website of the University Hospital Ghent	View source

Intervention Browse Module

MeSH Terms

ID	Term
D006024	Glycopyrrolate

Ancestor Terms

ID	Term
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals
D009861	Onium Compounds

Browse Leaves

Not provided

Browse Branches

Not provided