NCT00315536

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2006

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

2.9 years

First QC Date

April 14, 2006

Last Update Submit

January 3, 2012

Conditions

Urological Surgery

Outcome Measures

Primary Outcomes (2)

  • Cardiac index

    Twice in 16 minutes.

  • Blood pressure

    Twice in 16 minutes.

Interventions

Administration of remifentanil and glycopyrrolateDRUG

2 mg, intravenius use

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • ASA I and II children
  • years
  • urological surgery

You may not qualify if:

  • Cardiac disease
  • Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Interventions

Glycopyrrolate

Intervention Hierarchy (Ancestors)

Quaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Koen Reyntjens, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2006

First Posted

April 18, 2006

Study Start

May 1, 2006

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

January 5, 2012

Record last verified: 2012-01

Locations

BE(1)