Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00213239
Status:
COMPLETED
Last Update Posted:
2019-12-02
First Post:
2005-09-13
Brief Title:
A Dose Finding Study of Remifentanil and Propofol for Lumbar Punctures in Children
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
The Minimum Effective Dose of Remifentanil When Co-administered With Propofol for Lumbar Puncture in Children A Dose-finding Study
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine whether the combination of two anaesthetic medications propofol and remifentanil is suitable for short duration surgical procedures providing a shorter recovery time and fewer side effects than either drug used alone
Detailed Description:
Propofol is the primary medication used by anesthesiologists at HSC to provide sedation for lumbar puncture Propofol provides amnesia anxiolysis and hypnosis but because propofol has no analgestic properties patients often respond to the pain of LP needle insertion To ensure patient immobility the dose of propofol is often increased resulting in a duration of action that is excessive for lumbar puncture Remifentanil is an ultra-short acting opioid which can be used to provide analgesia and sedation for short painful procedures with minimal residual pain However when used as the sole agent remifentanil is associated with a high incidence of respiratory depression andor arterial oxygen desaturation and does not provide amnesia or anxiolysis The combination of propofol and remifentanil may be particularly suitable for short duration procedures providing a shorter recovery time and fewer side effects than either drug used alone
The objective is to determine the minimum effective dose of remifentanil required to prevent movement for insertion of a lumbar puncture needle when co-administered with propofol The results obtained from this study will be used in a future study of the recovery characteristics of propofol and remifentanil in children undergoing lumbar puncture
The objective is to determine the minimum effective dose of remifentanil required to prevent movement for insertion of a lumbar puncture needle when co-administered with propofol The results obtained from this study will be used in a future study of the recovery characteristics of propofol and remifentanil in children undergoing lumbar puncture
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None