Comparison Between Intrathecal Magnesium Sulphate & Dexmedetomidine in DHS

NCT ID: NCT07326397

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2027-12-01

Brief Summary

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.

Detailed 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.

Conditions

Effects of Dexmedetomidine & Magnesium Sulphate on Patients Undergoing DHS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Group D (Dexmedetomidine)

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

2.5 mL 0.5% hyperbaric bupivacaine + 5 µg dexmedetomidine (0.5 mL), total volume 3 mL

Group M (Magnesium Sulphate)

Group Type: ACTIVE_COMPARATOR

Magnesium Sulphate

Intervention Type: DRUG

2.5 mL 0.5% hyperbaric bupivacaine + 50 mg magnesium sulphate (0.5 mL), total volume 3 mL

Interventions

Magnesium Sulphate

2.5 mL 0.5% hyperbaric bupivacaine + 50 mg magnesium sulphate (0.5 mL), total volume 3 mL

Intervention Type: DRUG

Dexmedetomidine

2.5 mL 0.5% hyperbaric bupivacaine + 5 µg dexmedetomidine (0.5 mL), total volume 3 mL

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Shehab Fathy Ahmed Osman

Resident doctor at Assiut University Hospital, Assiut, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Intrathecal Mgso4& Dex. In DHS

Identifier Type: -

Identifier Source: org_study_id