Dexmedetomidine Versus Magnesium Sulfate Infusion in Craniotomy
Effect of Dexmedetomidine Versus Magnesium Sulfate Infusion on Intracranial Pressure and Cerebral Perfusion Pressure in Craniotomy Using Lumbar Drain Catheter
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
To compare the intraoperative effects of Dexmedetomidine and Magnesium Sulfate infusion on intracranial pressure and cerebral perfusion pressure in adult patients undergoing craniotomy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2025
CompletedFirst Posted
Study publicly available on registry
September 30, 2025
CompletedStudy Start
First participant enrolled
October 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
September 30, 2025
September 1, 2025
12 months
September 22, 2025
September 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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)
Study Arms (2)
Dexmedetomidine
ACTIVE COMPARATORDexmedetomidine: 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 COMPARATORMagnesium 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Coagulopathy or current anticoagulation
- Severe renal or hepatic dysfunction
- Known allergy to study medications
- traumatic brain injury
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
September 22, 2025
First Posted
September 30, 2025
Study Start
October 20, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
September 30, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share