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Comparison Between Intrathecal Magnesium Sulphate & Dexmedetomidine in DHS

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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07326397
Enrollment
92
Registered
2026-01-08
Start date
2026-02-01
Completion date
2027-12-01
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effects of Dexmedetomidine & Magnesium Sulphate on Patients Undergoing DHS

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.

Interventions

DRUGDexmedetomidine

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

DRUGMagnesium Sulphate

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Highest Dermatome Level of Sensory Block24 hours after interventionSensory block level assessed using a pinprick test and recorded as the highest dermatome level with loss of sensation.
Duration of postoperative analgesia24 hours after interventionThe 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.
Degree of Motor Block24 hours after interventionMotor block assessed using the Modified Bromage Scale (0-3), where higher scores indicate greater motor block.

Secondary

MeasureTime frameDescription
Heart Rate24 hours after interventionHeart rate measured in beats per minute (bpm)
Oxygen Saturation24 hours after interventionPeripheral oxygen saturation measured by pulse oximetry by percentage
Incidence of Adverse Effects24 hours after InterventionBradycardia 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)
Mean Arterial Pressure24 hours after interventionMean arterial pressure measured in mmHg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026