Comparison Between Intrathecal Magnesium Sulphate & Dexmedetomidine in DHS
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, Magnesium Sulphate.
- Who it may be relevant to
- Registry conditions: Effects of Dexmedetomidine & Magnesium Sulphate on Patients Undergoing DHS. 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
Comparative Evaluation of Intrathecal Dexmedetomidine and Magnesium Sulphate as Adjuvants to 0.5% Hyperbaric Bupivacaine for Spinal Anesthesia in Patients Undergoing Dynamic Hip Screw (DHS) Fixation: A Randomized Clinical Study
Overview
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.
Interventions
- Drug Dexmedetomidine
2.5 mL 0.5% hyperbaric bupivacaine + 5 µg dexmedetomidine (0.5 mL), total volume 3 mL - Drug Magnesium Sulphate
2.5 mL 0.5% hyperbaric bupivacaine + 50 mg magnesium sulphate (0.5 mL), total volume 3 mL
Primary outcome measures
- Highest Dermatome Level of Sensory Block [Time frame: 24 hours after intervention]
- Duration of postoperative analgesia [Time frame: 24 hours after intervention]
- Degree of Motor Block [Time frame: 24 hours after intervention]
Secondary outcome measures (4)
- Heart Rate [Time frame: 24 hours after intervention]
- Incidence of Adverse Effects [Time frame: 24 hours after Intervention]
- Mean Arterial Pressure [Time frame: 24 hours after intervention]
- Oxygen Saturation [Time frame: 24 hours after intervention]
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
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
- Triple blind
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07326397 · Intrathecal Mgso4& Dex. In DHS