Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07326397

Comparison Between Intrathecal Magnesium Sulphate & Dexmedetomidine in DHS

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Magnesium sulphate

Drug

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

Primary outcomes

  1. Highest Dermatome Level of Sensory Block

    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.

  2. Duration of postoperative analgesia

    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.

  3. Degree of Motor Block

    Time frame: 24 hours after intervention

    Motor block assessed using the Modified Bromage Scale (0-3), where higher scores indicate greater motor block.

Secondary outcomes

  1. Heart Rate

    Time frame: 24 hours after intervention

    Heart rate measured in beats per minute (bpm)

  2. Incidence of Adverse Effects

    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)

  3. Mean Arterial Pressure

    Time frame: 24 hours after intervention

    Mean arterial pressure measured in mmHg

  4. Oxygen Saturation

    Time frame: 24 hours after intervention

    Peripheral oxygen saturation measured by pulse oximetry by percentage

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.