An interventional study of Dexamedomedine and MgSO4 in Craniotomy Surgery, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-30.
Sponsored by Assiut University · Not applicable, Interventional, and Other
To compare the intraoperative effects of Dexmedetomidine and Magnesium Sulfate infusion on intracranial pressure and cerebral perfusion pressure in adult patients undergoing craniotomy
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
Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
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Exclusion Criteria:
Dexmedetomidine: loading dose 1 µg/kg IV over 10 min after induction and then maintenance dose 0.2- 0.7 µg/kg/hr based on hemodynamic response
Drug: Dexamedomedine
Magnesium Sulfate: Used as an IV loading dose at 20 mg/kg IV over 17 minutes as an induction agent, followed by maintenance of 10 mg/kg/h to skin closure.
Drug: MgSO4
Group A (the Dexmedetomidine group): Dexmedetomidine: loading dose 1 µg/kg IV over 10 min after induction and then maintenance dose 0.2- 0.7 µg/kg/hr based on hemodynamic response.
Magnesium Sulfate: Used as an IV loading dose at 20 mg/kg IV over 17 minutes as an induction agent, followed by maintenance of 10 mg/kg/h
Change in ICP and CPP in craniotomy
compare the intraoperative intracranial pressure (ICP) and cerebral perfusion pressure (CPP) effects of dexmedetomidine and magnesium sulfate infusion in a comparative study to determine the efficacy in adult patients undergoing craniotomy, continuous measurement was achieved with the help of a lumbar drain catheter.
Time frame: o Pre-loading o After loading o Once the patient is in position (other than baseline) o After 30 min of incision (or every 30-60 min till skin closure)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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Assiut University