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Mg Sulfate Versus Dexmedetomidine on Cerebral Oxygen Saturation

Effects of Dexmedetomidine Versus Magnesium Sulfate on Cerebral Oxygen Saturation During Spine Surgery: a Prospective Randomized Controlled Study

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06848595
Acronym
mg/dex/rSO2
Enrollment
90
Registered
2025-02-27
Start date
2025-02-23
Completion date
2027-01-31
Last updated
2025-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Desaturation Events, Spine Surgeries

Brief summary

This study is to evaluate the effects of dexmedetomidine and magnesium sulfate on cerebral oxygen saturation in patients undergoing spine surgeries as adjuvant to general anesthesia guided by cerebral oximetry. The main aims to are Incidence of cerebral desaturation events and duration of cerebral desaturation events.

Interventions

PROCEDUREspine surgery

spine surgery in prone position

DRUGMagnesium sulfate

Patients will receive loading dose of 40 mg/kg of magnesium sulfate diluted in 50 ml of 0.9% saline IVI will be given in 10 min before anesthesia induction then continuous infusion of 10 mg/kg/hour during the surgery.

DRUGDexmedetomidine

Patients will receive loading dose of 1 mcg/kg dexmedetomidine diluted in 50 ml of saline 0.9% IVI will be given in 10 min before anesthesia induction then continuous infusion of 0.5 mcg/kg/hour during the surgery.

DRUGNormal Saline (0.9% NaCl)

Patients will receive the same volume of normal saline.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Age from 21 to 60 years old. * either gender. * American Society of Anesthesiologists (ASA) physical status I and II.

Exclusion criteria

* Patient refusal to participate in research. * History of preoperative neuromuscular disease. * Patients with preexisting cerebral pathology (such as previous episodes of cerebral ischemia or stroke). * History of psychiatric illness. * History of orthostatic hypotension, myocardial infarction, uncontrolled hypertension or documented carotid stenosis. * Coagulopathy disorder. * Patients receiving magnesium supplementation. * Chronic use of opioids. * Current treatment with a β-blocker or calcium channel blocker.

Design outcomes

Primary

MeasureTime frame
Incidence of cerebral desaturation events.intraoperative

Secondary

MeasureTime frame
Duration of cerebral desaturation eventsintraoperative
change in heart rate in beatsintraoperative
change in blood pressure in mmHgIntraoperative

Contacts

Primary ContactIbrahim Elsayed Elnefiawy, assisstant lectuerer
aborazan171@gmail.com00201001515007
Backup ContactNadia Elsayed Elafify, assistant lectuerer
nadiaelsayed225@gmail.com0020110627640

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026