Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-31 @ 1:58 AM
Study NCT ID:
NCT07199595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine Versus Magnesium Sulfate Infusion in Craniotomy
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Effect of Dexmedetomidine Versus Magnesium Sulfate Infusion on Intracranial Pressure and Cerebral Perfusion Pressure in Craniotomy Using Lumbar Drain Catheter
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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:
To compare the intraoperative effects of Dexmedetomidine and Magnesium Sulfate infusion on intracranial pressure and cerebral perfusion pressure in adult patients undergoing craniotomy
Detailed Description:
Intracranial pressure (ICP) and cerebral perfusion pressure (CPP) are critical parameters in craniotomy patients . Effective modulation of these pressures during surgery can improve intraoperative stability and postoperative recovery . Dexmedetomidine (Dexamed) is a selective α2-adrenoceptor agonist with sedative and neuroprotective properties, known to reduce ICP without respiratory depression . Magnesium Sulfate (MgSO₄) acts as an NMDA receptor antagonist and vasodilator, promoting neuronal protection and improved cerebral blood flow . By using a lumbar drain catheter intraoperatively, direct and continuous measurement of ICP is feasible, offering real-time insight into the pharmacological effects of these agents on cerebral dynamics .
The underlying research question is as follows: Can intraoperative Dexmedetomidine as opposed to Magnesium sulfate result in better ICP and CPP management of adult craniotomy patients? Nonetheless, the individual basis of usage of Dexmedetomidine and Magnesium Sulfate in neurosurgeries has been supported by existing literature , but lack of direct comparative studies to determine the effects of the two drugs on real-time intracranial and cerebral perfusion pressure in the craniotomy . This study aims to fill the existing gap in the literature by stating the continuity of ICP monitoring with a lumbar drain, thus offering a robust and standard control environment of comparison.
Intervention Protocol
Participants will be randomly assigned to one of two groups:
Group A - Dexmedetomidine Infusion
* Loading Dose: 1 µg/kg IV over 10 minutes
* Maintenance Infusion: 0.2-0.7 µg/kg/h, titrated based on sedation level and hemodynamic response
* Infusion will carry on till skin closure.
* Monitoring: MAP, HR, ICP, CPP Group B - Magnesium Sulfate Infusion
* Loading Dose: 20 mg/kg IV over 15 minutes
* Maintenance Infusion: 10 mg/kg/h throughout the procedure
* Infusion will carry on till skin closure.
* Monitoring: MAP, HR, ICP, CPP
The underlying research question is as follows: Can intraoperative Dexmedetomidine as opposed to Magnesium sulfate result in better ICP and CPP management of adult craniotomy patients? Nonetheless, the individual basis of usage of Dexmedetomidine and Magnesium Sulfate in neurosurgeries has been supported by existing literature , but lack of direct comparative studies to determine the effects of the two drugs on real-time intracranial and cerebral perfusion pressure in the craniotomy . This study aims to fill the existing gap in the literature by stating the continuity of ICP monitoring with a lumbar drain, thus offering a robust and standard control environment of comparison.
Intervention Protocol
Participants will be randomly assigned to one of two groups:
Group A - Dexmedetomidine Infusion
* Loading Dose: 1 µg/kg IV over 10 minutes
* Maintenance Infusion: 0.2-0.7 µg/kg/h, titrated based on sedation level and hemodynamic response
* Infusion will carry on till skin closure.
* Monitoring: MAP, HR, ICP, CPP Group B - Magnesium Sulfate Infusion
* Loading Dose: 20 mg/kg IV over 15 minutes
* Maintenance Infusion: 10 mg/kg/h throughout the procedure
* Infusion will carry on till skin closure.
* Monitoring: MAP, HR, ICP, CPP
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: