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NCT Number: NCT07199595

Dexmedetomidine Versus Magnesium Sulfate Infusion in Craniotomy

To compare the intraoperative effects of Dexmedetomidine and Magnesium Sulfate infusion on intracranial pressure and cerebral perfusion pressure in adult patients undergoing craniotomy

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamedomedine

Drug

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

Drug

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 outcomes

  1. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ghada Aboalfadl, Professor

CONTACT

[email protected]

Hassan mostafa, Assistant lecturer

CONTACT

[email protected]

01060264751

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effect of Dexmedetomidine Versus Magnesium Sulfate Infusion on Intracranial Pressure and Cerebral Perfusion Pressure in Craniotomy Using Lumbar Drain Catheter

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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