Echocardiographic Study of the Haemodynamic Effects of Remifentanil With and Without Glycopyrrolate in Healthy Children
This study has been completed.
Sponsor:
University Hospital, Ghent
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00315536
First received: April 14, 2006
Last updated: January 3, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Urological Surgery |
Drug: Administration of remifentanil and glycopyrrolate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Echocardiographic Study of the Haemodynamic Effects of Remifentanil With and Without Glycopyrrolate in Healthy Children |
Resource links provided by NLM:
Further study details as provided by University Hospital, Ghent:
Primary Outcome Measures:
- Cardiac index [ Time Frame: Twice in 16 minutes. ] [ Designated as safety issue: No ]
- Blood pressure [ Time Frame: Twice in 16 minutes. ] [ Designated as safety issue: No ]
| Enrollment: | 63 |
| Study Start Date: | May 2006 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Administration of remifentanil and glycopyrrolate
2 mg, intravenius use
Eligibility| Ages Eligible for Study: | 1 Year to 6 Years (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- ASA I and II children
- 1-6 years
- urological surgery
Exclusion Criteria:
- Cardiac disease
- Diabetes
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00315536
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315536
Locations
| Belgium | |
| University Hospital Ghent | |
| Ghent, Belgium, 9000 | |
Sponsors and Collaborators
University Hospital, Ghent
Investigators
| Principal Investigator: | Koen Reyntjens, MD | University Hospital, Ghent |
More Information
Additional Information:
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT00315536 History of Changes |
| Other Study ID Numbers: | 2006/042 |
| Study First Received: | April 14, 2006 |
| Last Updated: | January 3, 2012 |
| Health Authority: | Belgium: Federal Agency for Medicines and Health Products, FAMHP |
Additional relevant MeSH terms:
|
Remifentanil Glycopyrrolate Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Hypnotics and Sedatives |
Anesthetics, Intravenous Anesthetics, General Anesthetics Adjuvants, Anesthesia Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 26, 2016