Mg Sulfate Versus Dexmedetomidine on Cerebral Oxygen Saturation

Phase 3

Not yet recruiting

• Conditions: Cerebral Desaturation Events; Spine Surgeries
• Interventions: Procedure: spine surgery; Drug: Magnesium sulfate; Drug: Dexmedetomidine; Drug: Normal Saline (0.9% NaCl)

• Registration Number: NCT06848595
• Lead Sponsor: Tanta University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-21
• Study Start: 2025-02-23
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-02-27
• Last Update Posted: 2025-02-27
• Primary Completion: 2027-01-20
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MgSO4	spine surgery	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.
MgSO4	Magnesium sulfate	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.
dex.	spine surgery	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.
dex.	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.
control	spine surgery	Patients will receive the same volume of normal saline.
control	Normal Saline (0.9% NaCl)	Patients will receive the same volume of normal saline.

Primary Outcome Measures

Name	Time	Method
Incidence of cerebral desaturation events.	intraoperative

Secondary Outcome Measures

Name	Time	Method
Duration of cerebral desaturation events	intraoperative
change in heart rate in beats	intraoperative
change in blood pressure in mmHg	Intraoperative