Mg Sulfate Versus Dexmedetomidine on Cerebral Oxygen Saturation (mg/dex/rSO2)

Tanta University

Status and phase: Not yet enrolling; Phase 3

Conditions: Cerebral Desaturation Events; Spine Surgeries

Treatments: Procedure: spine surgery; Drug: Magnesium sulfate; Drug: Dexmedetomidine; Drug: Normal Saline (0.9% NaCl)

Study type: Interventional

Funder types: Other

Identifiers

NCT06848595

36265MD317/11/24

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

MgSO4

Active Comparator group

Description:

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.

Treatment:

Drug: Magnesium sulfate

Procedure: spine surgery

dex.

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Procedure: spine surgery

control

Placebo Comparator group

Description:

Patients will receive the same volume of normal saline.

Treatment:

Drug: Normal Saline (0.9% NaCl)

Procedure: spine surgery