Dexmedetomidine Versus Magnesium Sulfate Infusion in Craniotomy
NCT ID: NCT07199595
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-10-20
2026-11-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Dexmedetomidine
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
Dexamedomedine
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.
Mgso4
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.
MgSO4
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
Interventions
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Dexamedomedine
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.
MgSO4
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
Eligibility Criteria
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Inclusion Criteria
* Elective craniotomy for supratentorial pathology
* No contraindication to lumbar drain insertion
* Baseline mental status is stable, allowing for a reliable postoperative neurological evaluation can be done
* ASA physical status I-III
Exclusion Criteria
* Severe renal or hepatic dysfunction
* Known allergy to study medications
* traumatic brain injury
18 Years
65 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Hassan mostafa abdelbaky ahmed
Assistant lecturer
Central Contacts
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Other Identifiers
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Icp
Identifier Type: -
Identifier Source: org_study_id