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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Desaturation Events; Spine Surgeries
• Intervention / Treatment: Procedure: spine surgery; Drug: Magnesium sulfate; Drug: Dexmedetomidine; Drug: Normal Saline (0.9% NaCl)

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ibrahim Elsayed Elnefiawy, assisstant lectuerer; Phone Number: 00201001515007; Email: aborazan171@gmail.com
• Study Contact Backup: Name: Nadia Elsayed Elafify, assistant lectuerer; Phone Number: 0020110627640; Email: nadiaelsayed225@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MgSO4; 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.	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.
Active Comparator: dex.; 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.	Procedure: spine surgery; spine surgery in prone position; 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.
Placebo Comparator: control; Patients will receive the same volume of normal saline.	Procedure: spine surgery; spine surgery in prone position; Drug: Normal Saline (0.9% NaCl); Patients will receive the same volume of normal saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of cerebral desaturation events.	intraoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of cerebral desaturation events	intraoperative
change in heart rate in beats	intraoperative
change in blood pressure in mmHg	Intraoperative

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Study Director: Ahmed Said Elgebaly, professor, Tanta university; Study Director: Shimaa Farouk Abdelkader, professor, Tanta university

Study record dates

Study Major Dates

• Study Start (Estimated): February 23, 2025
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: February 26, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Reproductive Control Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Anti-Arrhythmia Agents; Membrane Transport Modulators; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Anticonvulsants; Calcium Channel Blockers; Tocolytic Agents; Dexmedetomidine; Magnesium Sulfate
• Other Study ID Numbers: 36265MD317/11/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes