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NCT Number: NCT07443163

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

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.

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Key information

Conditions

Emergence From Anesthesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine (Precedex®)

Drug

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

Magnesium sulfate

Drug

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 outcomes

  1. Extubation time

    Time frame: Up to 2 hours after surgery

    Time from stoppage of TIVA infusion till extubation of the endotracheal tube

Secondary outcomes

  1. Time to the first request for the rescue analgesia

    Time frame: Up to 24 hours after surgery

    time from the end of surgery to the first dose of morphine administrated

  2. Total morphine consumption

    Time frame: 24 hours postoperative

  3. Ramsay Sedation score

    Time frame: 24 hours postoperative

    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

  4. Degree of patient satisfaction

    Time frame: 24 hours postoperative

    Will be assessed on a 5-point Likert scale (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied

  5. Incidence of adverse events

    Time frame: 24 hours postoperative

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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