Comparison Between Total Intravenous Anesthesia With Magnesium Sulphate Versus Total Intravenous Anesthesia With Dexmedetomidine in Patients Undergoing Lumbar Spine Surgeries
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: Dexmedetomidine (Precedex®), magnesium sulfate.
- Who it may be relevant to
- Registry conditions: Emergence From Anesthesia. Basic parameters: 18 years — 65 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
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
Overview
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.
Interventions
- 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 - 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
Primary outcome measures
- Extubation time [Time frame: Up to 2 hours after surgery]
Secondary outcome measures (5)
- Time to the first request for the rescue analgesia [Time frame: Up to 24 hours after surgery]
- Total morphine consumption [Time frame: 24 hours postoperative]
- Ramsay Sedation score [Time frame: 24 hours postoperative]
- Degree of patient satisfaction [Time frame: 24 hours postoperative]
- Incidence of adverse events [Time frame: 24 hours postoperative]
Eligibility criteria
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.
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
- Double blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07443163 · MD-313-2025