Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199511
Status:
COMPLETED
Last Update Posted:
2018-11-06
First Post:
2005-09-13
Brief Title:
Hypertonic Saline 75 vs Mannitol 20
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Comparison of Equiosmolar Doses of Mannitol 20 Versus Hypertonic Saline 75 Infusion in the Reduction of Brain Bulk During Elective Craniotomies for Supratentorial Brain Tumor Resection
Status:
COMPLETED
Status Verified Date:
2018-11
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:
The purpose of this study is to evaluate the effect of Hypertonic Saline 75 vs Mannitol 20 on brain bulk using a 4 point scale intracranial pressure subdural catheterand the changes on serum and urinary Na K and Osmolarity during elective craniotomy for brain tumor resection
Detailed Description:
Raised intracranial pressure occurs following an expansion of an intracranial mass eg hematoma or brain tumor and if left untreated can lead to brain ischemia stroke and death
Strategies for reducing raised intracranial pressure include hyperventilation use of a hyperosmolar agent and the evacuation of the intracranial mass
The two hypertonic solutions most commonly used are Mannitol 20 and Hypertonic Saline 75
During elective neurosurgical removal of a brain tumour the anesthesiologist needs to reduce intracranial pressure and provide good operating brain conditions to avoid brain ischemia
Currently Mannitol 20 is routinely used intra-operatively in these patients to reduce brain bulk and intracranial pressure and to improve brain operating conditions
However Mannitol itself can cause secondary effects that can be deleterious to the neurological patient Mannitol causes a diuresis which may lead to systemic hypovolemia and hypotension and adverse changes in serum and urinary sodium potassium and osmolarity
Experience with Hypertonic saline 75 has been mainly in brain injured patients either in the Emergency Dept or in the Intensive care setting There is growing evidence that Hypertonic saline 75 is just as effective as Mannitol 20 in reducing raised intracranial pressure especially in traumatic brain injury and it has become a widely accepted form of treatment One of the advantages of Hypertonic saline is that it does not cause a diuresis and therefore less likely to cause hypotension and hypovolemia While transient hypernatremia has been observed after the administration of hypertonic saline there have been no clinical consequences
Unfortunately there have been only two studies which compared the effectiveness of Hypertonic saline and Mannitol during elective brain surgery One of them Gemma et al failed to demonstrate any difference in the reduction of brain bulk between Mannitol and Hypertonic saline However the 2 solutions used had different osmolarities and this may have had a confounding effect on the results In the other study published in Polish the authors found a 20 reduction in brain bulk in favour of hypertonic saline In view of these two opposing findings we feel that another investigation is warranted
Strategies for reducing raised intracranial pressure include hyperventilation use of a hyperosmolar agent and the evacuation of the intracranial mass
The two hypertonic solutions most commonly used are Mannitol 20 and Hypertonic Saline 75
During elective neurosurgical removal of a brain tumour the anesthesiologist needs to reduce intracranial pressure and provide good operating brain conditions to avoid brain ischemia
Currently Mannitol 20 is routinely used intra-operatively in these patients to reduce brain bulk and intracranial pressure and to improve brain operating conditions
However Mannitol itself can cause secondary effects that can be deleterious to the neurological patient Mannitol causes a diuresis which may lead to systemic hypovolemia and hypotension and adverse changes in serum and urinary sodium potassium and osmolarity
Experience with Hypertonic saline 75 has been mainly in brain injured patients either in the Emergency Dept or in the Intensive care setting There is growing evidence that Hypertonic saline 75 is just as effective as Mannitol 20 in reducing raised intracranial pressure especially in traumatic brain injury and it has become a widely accepted form of treatment One of the advantages of Hypertonic saline is that it does not cause a diuresis and therefore less likely to cause hypotension and hypovolemia While transient hypernatremia has been observed after the administration of hypertonic saline there have been no clinical consequences
Unfortunately there have been only two studies which compared the effectiveness of Hypertonic saline and Mannitol during elective brain surgery One of them Gemma et al failed to demonstrate any difference in the reduction of brain bulk between Mannitol and Hypertonic saline However the 2 solutions used had different osmolarities and this may have had a confounding effect on the results In the other study published in Polish the authors found a 20 reduction in brain bulk in favour of hypertonic saline In view of these two opposing findings we feel that another investigation is warranted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None