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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 92
- 主要终点
- Highest Dermatome Level of Sensory Block
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patient refusal
- •Allergy to study drugs
- •Local infection at injection site
- •Neurological or psychiatric illness
- •Coagulopathy
- •Chronic opioid or sedative use
研究组 & 干预措施
Group D (Dexmedetomidine)
干预措施: Dexmedetomidine (Drug)
Group M (Magnesium Sulphate)
干预措施: Magnesium Sulphate (Drug)
结局指标
主要结局
Highest Dermatome Level of Sensory Block
时间窗: 24 hours after intervention
Sensory block level assessed using a pinprick test and recorded as the highest dermatome level with loss of sensation.
Duration of postoperative analgesia
时间窗: 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.
Degree of Motor Block
时间窗: 24 hours after intervention
Motor block assessed using the Modified Bromage Scale (0-3), where higher scores indicate greater motor block.
次要结局
- Heart Rate(24 hours after intervention)
- Incidence of Adverse Effects(24 hours after Intervention)
- Mean Arterial Pressure(24 hours after intervention)
- Oxygen Saturation(24 hours after intervention)
研究者
Shehab Fathy Ahmed Osman
Resident doctor at Assiut University Hospital, Assiut, Egypt
Assiut University