Craniotomy SurgeryNCT07199595
Dexmedetomidine Versus Magnesium Sulfate Infusion in Craniotomy
A study testing Dexamedomedine and MgSO4 in people with Craniotomy Surgery, run by Assiut University.
Trial summary
To compare the intraoperative effects of Dexmedetomidine and Magnesium Sulfate infusion on intracranial pressure and cerebral perfusion pressure in adult patients undergoing craniotomy Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Craniotomy Surgery
- What is being tested?
- Dexamedomedine and MgSO4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Coagulopathy or current anticoagulation
- Severe renal or hepatic dysfunction
- Known allergy to study medications
- traumatic brain injury
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ghada Aboalfadl, Professor contact
About this study
Official title: Effect of Dexmedetomidine Versus Magnesium Sulfate Infusion on Intracranial Pressure and Cerebral Perfusion Pressure in Craniotomy Using Lumbar Drain Catheter
To compare the intraoperative effects of Dexmedetomidine and Magnesium Sulfate infusion on intracranial pressure and cerebral perfusion pressure in adult patients undergoing craniotomy
Read the 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
- Conditions
- Craniotomy Surgery
- Being tested
- Dexamedomedine, MgSO4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamedomedineDrug
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.
MgSO4Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | 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 Receives: Drug: Dexamedomedine |
| Mgso4 | Active comparator | 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. Receives: Drug: MgSO4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start20 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniotomy SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan mostafa abdelbaky ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199595
- Sponsor's protocol ID
- Icp
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine Versus Magnesium Sulfate Infusion on Intracranial Pressure and Cerebral Perfusion Pressure in Craniotomy Using Lumbar Drain Catheter
- ClinicalTrials.gov ID
- NCT07199595
- Acronym / sponsor ID
- Icp
- Conditions
- Craniotomy Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: DexamedomedineDexmedetomidine: 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 | Active comparator | Drug: MgSO4Magnesium 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Coagulopathy or current anticoagulation
- Severe renal or hepatic dysfunction
- Known allergy to study medications
- traumatic brain injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamedomedineGroup 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 | Dexmedetomidine |
| MgSO4Magnesium 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 | Drug | Mgso4 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ghada Aboalfadl, Professor contact
Questions about this trial
What is this clinical trial studying?
A study testing Dexamedomedine and MgSO4 in people with Craniotomy Surgery, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hassan mostafa, Assistant lecturer (01060264751, hassan.mostafa9444@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.