Comparison Between Intrathecal Magnesium Sulphate & Dexmedetomidine in DHS

Assiut University

Status and phase: Not yet enrolling; Phase 3

Conditions: Effects of Dexmedetomidine & Magnesium Sulphate on Patients Undergoing DHS

Treatments: Drug: Dexmedetomidine; Drug: Magnesium Sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT07326397

Intrathecal Mgso4& Dex. In DHS

Details and patient eligibility

About

To compare the efficacy and safety of intrathecal dexmedetomidine and magnesium sulphate as adjuvants to 0.5% hyperbaric bupivacaine in patients undergoing elective DHS fixation, focusing on onset and duration of sensory and motor block, hemodynamic stability, and quality of postoperative analgesia.

Full description

Spinal anesthesia is a preferred technique for lower limb orthopedic surgeries due to its rapid onset, reliable sensory and motor blockade, and minimal systemic side effects. Hyperbaric bupivacaine 0.5% is commonly used; however, its duration may be insufficient for prolonged procedures or postoperative analgesia. To enhance and prolong anesthesia and analgesia, various intrathecal adjuvants have been investigated.

Dexmedetomidine, a selective α2-adrenergic agonist, has shown promise in improving the quality and duration of spinal anesthesia by providing prolonged sensory and motor blockade, stable hemodynamics, and enhanced postoperative analgesia. Similarly, magnesium sulphate, an NMDA receptor antagonist, exerts antinociceptive effects by modulating calcium influx in nerve cells, potentially prolonging analgesia without significant motor blockade.

Dynamic hip screw (DHS) fixation is a common surgical intervention for intertrochanteric femur fractures, particularly in elderly patients. These procedures demand reliable intraoperative anesthesia and effective postoperative pain control to facilitate early mobilization and reduce complications.

Despite individual studies evaluating these agents, direct comparisons between intrathecal dexmedetomidine and magnesium sulphate as adjuvants to bupivacaine in DHS fixation remain limited. This study aims to compare their efficacy and safety in enhancing spinal anesthesia, thereby optimizing perioperative care in patients undergoing elective DHS fixation.

Enrollment: 92 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18-65 year
• ASA Physical Status I or II
• Scheduled for elective DHS fixation under spinal anesthesia
• Written informed consent provided
• Patients of both sex are included in the study.

Exclusion criteria

• Patient refusal
• Allergy to study drugs
• Local infection at injection site
• Neurological or psychiatric illness
• Coagulopathy
• Chronic opioid or sedative use

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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92 participants in 2 patient groups

Group D (Dexmedetomidine)

Active Comparator group

Treatment:

Drug: Dexmedetomidine

Group M (Magnesium Sulphate)

Active Comparator group

Treatment:

Drug: Magnesium Sulphate