Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00437814
Status:
UNKNOWN
Last Update Posted:
2007-02-21
First Post:
2007-02-19
Brief Title:
Effect of Ketamine Ketalar on Intracranial Pressure
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
Effect of Ketamine Ketalar on Intracranial Pressure
Status:
UNKNOWN
Status Verified Date:
2007-02
Last Known Status:
RECRUITING
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:
Objectives Ketamine is an effective short-acting anesthetic drug which does not decrease blood pressure It is widely stated that Ketamine increases intracranial pressure ICP which prevents its use in many emergency situations specifically in patients with traumatic brain injury TBI and with increased ICP Based on previous clinical experience we hypothesized that Ketamine decreases - rather than increases - ICP
Methods Prospective controlled clinical trial Children with ICP monitoring will receive a single Ketamine dose 1-15 mgkg either for increased ICP andor before a potentially distressing activity Hemodynamic variables ICP and cerebral perfusion pressure CPP will be recorded 1 minute before and every minute for 10 minutes following Ketamine administration Beforeafter design
Methods Prospective controlled clinical trial Children with ICP monitoring will receive a single Ketamine dose 1-15 mgkg either for increased ICP andor before a potentially distressing activity Hemodynamic variables ICP and cerebral perfusion pressure CPP will be recorded 1 minute before and every minute for 10 minutes following Ketamine administration Beforeafter design
Detailed Description:
Objectives Ketamine is an effective safe rapid short-acting anesthetic drug and - contrary to all other anesthetic drugs - it does not decrease blood pressure It is widely believed that Ketamine increases intracranial pressure ICP which prevents its use in many emergency situations including trauma and specifically in patients with traumatic brain injury TBI and with increased ICP Based on our previous clinical experience in patients with ICP monitoring Ketamine did not increase ICP We therefore hypothesize that Ketamine decreases - rather than increases - ICP
Methods Prospective controlled clinical trial performed in a Pediatric ICU of a regional trauma center Children with ICP monitoring receive a single Ketamine dose 1-15 mgkg either for increased ICP andor before a potentially distressing activity Hemodynamic variables ICP and cerebral perfusion pressure CPP will be recorded 1 minute before and every minute for 10 minutes following Ketamine administration beforeafter study design
Parentsguardian of patients will be informed and asked to sign an informed consent
Methods Prospective controlled clinical trial performed in a Pediatric ICU of a regional trauma center Children with ICP monitoring receive a single Ketamine dose 1-15 mgkg either for increased ICP andor before a potentially distressing activity Hemodynamic variables ICP and cerebral perfusion pressure CPP will be recorded 1 minute before and every minute for 10 minutes following Ketamine administration beforeafter study design
Parentsguardian of patients will be informed and asked to sign an informed consent
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