Ignite Creation Date:
2024-05-06 @ 1:50 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04135456
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-30
First Post:
2019-09-11
Brief Title:
The Optimal Dose of Mannitol for Intraoperative Brain Relaxation During the Operation of Aneurysmal Subarachnoid Hemorrhage
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
Study on the Optimal Dosage of Mannitol in Aneurysmal Subarachnoid Hemorrhage Craniotomy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
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:
ODAS
Brief Summary:
Aneurysmal subarachnoid hemorrhage aSAH tended to lead to a sudden increase in intracerebral pressure ICP which can cause decreased cerebral perfusion and transient global cerebral ischemia Early clipping and coiling of aneurysms and surgical evacuation of intracerebral hematoma were recommended for aSAH patients However the high ICP made it difficult to separate the subarachnoid space during the operation Effective reduction of ICP was the key to the succession of the operation But there is a lack of consensus on the management of raised ICP in aSAH Mannitol is widely used to reduce ICP in patients with cerebral edema The potential mechanism including decreasing the viscosity of the blood improving regional cerebral microvascular flow and oxygenation and increasing intravascular volume due to increased plasma osmolality The magnitude of the pressure reduction was correlated with the intact intracranial automatic adjustment function However the hypochloremic metabolic alkalosis hypernatremia hypokalemia and renal failure associated with mannitol overdose must be considered and the effective dose and the duration of its administration were still unknown The aims of this study were to determine the most appropriate mannitol dose to provide adequate brain relaxation in aSAH patients with the fewest adverse effects
Detailed Description:
None
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