Dexmedetomidine
Drug2.5 mL 0.5% hyperbaric bupivacaine + 5 µg dexmedetomidine (0.5 mL), total volume 3 mL
NCT Number: NCT07326397
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Phase 3
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2.5 mL 0.5% hyperbaric bupivacaine + 5 µg dexmedetomidine (0.5 mL), total volume 3 mL
2.5 mL 0.5% hyperbaric bupivacaine + 50 mg magnesium sulphate (0.5 mL), total volume 3 mL
Time frame: 24 hours after intervention
Sensory block level assessed using a pinprick test and recorded as the highest dermatome level with loss of sensation.
Time frame: 24 hours after intervention
The outcome is Measured by Vas Score to assess pain intensity. It consists of a numeric version of the visual analogue scale. It is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. This scale can be administered verbally. Vas score for 24 h will be assessed at 0., 1, 12 and 24 h postoperatively and will be recorded.
Time frame: 24 hours after intervention
Motor block assessed using the Modified Bromage Scale (0-3), where higher scores indicate greater motor block.
Time frame: 24 hours after intervention
Heart rate measured in beats per minute (bpm)
Time frame: 24 hours after Intervention
Bradycardia Hypotension Nausea Vomiting Sedation (Assessed By Ramsay Sedation Scale (RSS) ) Shivering Respiratory depression Delayed motor block Flushing Warm sensation Headache Pruritus Urinary retention Neurological complications (e.g., transient paresthesia)
Time frame: 24 hours after intervention
Mean arterial pressure measured in mmHg
Time frame: 24 hours after intervention
Peripheral oxygen saturation measured by pulse oximetry by percentage
Assiut University
Other
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
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