Mg Sulfate Versus Dexmedetomidine on Cerebral Oxygen Saturation
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: spine surgery, Magnesium sulfate, Dexmedetomidine, Normal Saline (0.9% NaCl).
- Who it may be relevant to
- Registry conditions: Cerebral Desaturation Events, Spine Surgeries. Basic parameters: 21 years — 60 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
Effects of Dexmedetomidine Versus Magnesium Sulfate on Cerebral Oxygen Saturation During Spine Surgery: a Prospective Randomized Controlled Study
Overview
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
- Procedure spine surgery
spine surgery in prone position - Drug Magnesium 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. - Drug Dexmedetomidine
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. - Drug Normal Saline (0.9% NaCl)
Patients will receive the same volume of normal saline.
Primary outcome measures
- Incidence of cerebral desaturation events. [Time frame: intraoperative]
Secondary outcome measures (3)
- Duration of cerebral desaturation events [Time frame: intraoperative]
- change in heart rate in beats [Time frame: intraoperative]
- change in blood pressure in mmHg [Time frame: Intraoperative]
Eligibility criteria
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.
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
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06848595 · 36265MD317/11/24