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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

American Society of Anesthesiologists (ASA) physical status I, II.

Scheduled for elective spine surgery up to two levels under general anesthesia

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group DActive comparator 1 intervention
Group B: Group MActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Extubation time

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

Time frame
Up to 2 hours after surgery

Secondary outcomes

1

Time to the first request for the rescue analgesia

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

Time frame
Up to 24 hours after surgery
2

Total morphine consumption

Time frame
24 hours postoperative
3

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

Time frame
24 hours postoperative
4

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

Time frame
24 hours postoperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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