Dexmedetomidine Versus Magnesium Sulfate Infusion in Craniotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexamedomedine, MgSO4.
- Who it may be relevant to
- Registry conditions: Craniotomy Surgery. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Dexmedetomidine Versus Magnesium Sulfate Infusion on Intracranial Pressure and Cerebral Perfusion Pressure in Craniotomy Using Lumbar Drain Catheter
Overview
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
Interventions
- Drug 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. - Drug 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
Primary outcome measures
- Change in ICP and CPP in craniotomy [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)]
Eligibility criteria
Inclusion criteria
- Age 18-65 years
- 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
- Coagulopathy or current anticoagulation
- Severe renal or hepatic dysfunction
- Known allergy to study medications
- traumatic brain injury
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07199595 · Icp