Comparison Between Total Intravenous Anesthesia With Magnesium Sulphate Versus Total Intravenous Anesthesia With Dexmedetomidine in Patients Undergoing Lumbar Spine Surgeries

Comparison Between Total Intravenous Anesthesia With Magnesium Sulphate Versus Total Intravenous Anesthesia With Dexmedetomidine in Patients Undergoing Lumbar Spine Surgeries on Extubation Time: A Randomized Double-Blinded Comparative Study

Although total intravenous anesthesia (TIVA) provides advantages such as accelerated recuperation and diminished postoperative nausea, it also has constraints, such as the potential for hemodynamic instability and inadequate analgesia. TIVA is less suitable for major surgeries, particularly those involving the spine, when used alone, due to these limitations, as they necessitate substantial muscle relaxation and pain management.

A non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, magnesium sulfate (MgSO4), exhibits antinociceptive properties. The infusion of Magnesium during general anesthesia has been shown to decrease the need for anesthesia and the consumption of postoperative analgesics in numerous clinical studies. MgSO4, when utilized as an adjunct to TIVA, has been demonstrated to decrease the duration of extubation, facilitate earlier emergence from anesthesia, and facilitate intraoperative neurophysiological monitoring (IOM) during spine surgery.

Dexmedetomidine is a selective α2-adrenoreceptor agonist whose sedative effects are predominantly mediated by its action on α-2 adrenergic receptors in the brain and spinal cord. It delivers efficient sedation without the pronounced respiratory depression that is frequently observed with other sedatives. Dexmedetomidine induces a profound sense of tranquility and alleviates anxiety by selectively targeting specific receptors in the central nervous system, in addition to offering analgesic advantages. Dexmedetomidine has been employed in the surgical intensive care unit to expedite the extubation process. Dexmedetomidine is now being utilized more frequently as an adjuvant for propofol-based TIVA in procedures that necessitateintraoperative neurophysiological monitoring.

There is a paucity of literature comparing TIVA with magnesium sulphate and TIVA with dexmedetomidine in spine surgeries.

Study Overview

• Status: Not yet recruiting
• Conditions: Emergence From Anesthesia
• Intervention / Treatment: Drug: Dexmedetomidine (Precedex®); Drug: magnesium sulfate

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status I, II.
• Scheduled for elective spine surgery up to two levels under general anesthesia

Exclusion Criteria:

• History of preoperative neuromuscular disease, hepatic impairment [defined as a known diagnosis of liver cirrhosis, hepatitis with elevated liver enzymes (>2 times upper standard limit), or Child-Pugh score B or C], renal impairment [defined as chronic kidney disease with an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² or history of dialysis], endocrinal disorders [including uncontrolled diabetes mellitus (HbA1c >8.5%), thyroid dysfunction (untreated hypo/hyperthyroidism), or adrenal insufficiency], hematological disorder [such as anemia (Hb <10 g/dL), coagulopathies (INR >1.5, platelet count <100,000/mm³), or bleeding diathesis] or cardiovascular dysfunction [defined as history of ischemic heart disease, arrhythmias requiring treatment, heart failure (NYHA class II or higher), or uncontrolled hypertension (SBP >160 mmHg or DBP >100 mmHg)].
• Any degree of heart block.
• Known allergy to the study drugs.
• Scoliosis surgery.
• Cervical spine surgeries.
• Surgeries with an anticipated duration of more than 4 hours.
• Receiving magnesium supplementation.
• Any Preoperative Disturbed consciousness level or cognitive dysfunction.
• Drugs known to have a significant interaction with NMDAs.
• Chronic use of opioids and current treatment with a β-blocker or calcium channel blocker.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group D	Drug: Dexmedetomidine (Precedex®); Patients will receive a dexmedetomidine loading dose of 1 µg/kg before induction over a period of 15 min and maintenance of 0.5 µg/kg/h throughout the surgery
Active Comparator: Group M	Drug: magnesium sulfate; Patients will receive a magnesium sulfate loading dose of 50 mg/kg before induction over a period of 15 min and maintenance at 15 mg/kg/h throughout the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extubation time	Time from stoppage of TIVA infusion till extubation of the endotracheal tube	Up to 2 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the first request for the rescue analgesia	time from the end of surgery to the first dose of morphine administrated	Up to 24 hours after surgery
Total morphine consumption		24 hours postoperative
Ramsay Sedation score	1, anxious or restless or both; 2, cooperative, oriented, relaxed; 3, responding to commands; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus	24 hours postoperative
Degree of patient satisfaction	Will be assessed on a 5-point Likert scale (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied	24 hours postoperative
Incidence of adverse events		24 hours postoperative

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Inorganic Chemicals; Sulfur Acids; Sulfates; Sulfuric Acids; Magnesium Compounds; Dexmedetomidine; Magnesium Sulfate
• Other Study ID Numbers: MD-313-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No