The Effects of Magnesium Sulphate as an Adjuvant to 0.5% Hyperbaric Levobupivacaine and Fentanyl in Patients Undergoing Lower Extremity Orthopedic Surgeries:A Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1. To compare the duration of postoperative analgesia (defined as the time to first request for
研究概览
简要总结
Before surgery, patients undergo a routine pre-anesthetic checkup, including an explanation of the visual analog scale for pain and the spinal anesthetic procedure, followed by obtaining written informed consent. On the day of surgery, patients are moved to the operation table where ASA standard monitoring (5-lead ECG, non-invasive blood pressure, and pulse oximeter) is applied, and an 18 G intravenous cannula is secured. Lactated Ringer’s solution is administered at 15 ml/kg body weight. A subarachnoid block is then performed by an experienced anesthesiologist using a midline approach with local infiltration at the L3-4 or L4-5 intervertebral space. A 25 G Quincke’s spinal needle is used to administer the anesthetic solution: 2.5 ml of 0.5% hyperbaric levobupivacaine, 0.4 ml of fentanyl, and either 0.1 ml of magnesium sulphate (Group M) or 0.1 ml of normal saline (Group S). Post-injection, patients are placed supine, and the primary investigator, who is blinded to the group allocation, monitors vital signs at specified intervals. Intraoperative management includes treating hypotension and bradycardia with appropriate medications and providing supplemental oxygen if needed. Sensory and motor blocks are assessed regularly using pinprick tests and the Modified Bromage Scale. If the block is insufficient, general anesthesia is administered. Post-surgery, patients are transferred to the post-anesthesia care unit for further monitoring and assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •18-65 years of age of either sex, ASA I or II, scheduled for orthopedic lower limb surgeries for like Total knee replacement, Arthroscopy, Open reduction internal fixation for lower limb fractures etc., duration of surgery ≤ 4hours.
排除标准
- •Patient refusal, local site infection, pregnancy, mental illness, chronic liver and renal diseases, deranged coagulation profile, history of scorpion bite.
结局指标
主要结局
1. To compare the duration of postoperative analgesia (defined as the time to first request for
时间窗: After subarachnoid block | Baseline | 2 min | 4 min | 6 min | 8 min | 10 min | 12 min | 14 min | 16 min | 18 min | 20 min | 35 min | 50 min | 65 min | 80 min | 95 min | 110 min | 125 min | 185 min | 245 min | Post Operative Monitoring | Baseline | 30min | 1 hr | 2 hr | 4 hr | 8 hr | 12 hr | 18 hr | 24 hr
rescue analgesia) between the group receiving 50 mg intrathecal magnesium sulfate with a
时间窗: After subarachnoid block | Baseline | 2 min | 4 min | 6 min | 8 min | 10 min | 12 min | 14 min | 16 min | 18 min | 20 min | 35 min | 50 min | 65 min | 80 min | 95 min | 110 min | 125 min | 185 min | 245 min | Post Operative Monitoring | Baseline | 30min | 1 hr | 2 hr | 4 hr | 8 hr | 12 hr | 18 hr | 24 hr
combination of 0.5% hyperbaric levobupivacaine and fentanyl and the control group receiving
时间窗: After subarachnoid block | Baseline | 2 min | 4 min | 6 min | 8 min | 10 min | 12 min | 14 min | 16 min | 18 min | 20 min | 35 min | 50 min | 65 min | 80 min | 95 min | 110 min | 125 min | 185 min | 245 min | Post Operative Monitoring | Baseline | 30min | 1 hr | 2 hr | 4 hr | 8 hr | 12 hr | 18 hr | 24 hr
only the combination of 0.5% hyperbaric levobupivacaine and fentanyl.
时间窗: After subarachnoid block | Baseline | 2 min | 4 min | 6 min | 8 min | 10 min | 12 min | 14 min | 16 min | 18 min | 20 min | 35 min | 50 min | 65 min | 80 min | 95 min | 110 min | 125 min | 185 min | 245 min | Post Operative Monitoring | Baseline | 30min | 1 hr | 2 hr | 4 hr | 8 hr | 12 hr | 18 hr | 24 hr
2. To evaluate the time to achieve adequate sensory and motor block (onset time) following spinal
时间窗: After subarachnoid block | Baseline | 2 min | 4 min | 6 min | 8 min | 10 min | 12 min | 14 min | 16 min | 18 min | 20 min | 35 min | 50 min | 65 min | 80 min | 95 min | 110 min | 125 min | 185 min | 245 min | Post Operative Monitoring | Baseline | 30min | 1 hr | 2 hr | 4 hr | 8 hr | 12 hr | 18 hr | 24 hr
anesthesia in both the magnesium sulfate and the control group.
时间窗: After subarachnoid block | Baseline | 2 min | 4 min | 6 min | 8 min | 10 min | 12 min | 14 min | 16 min | 18 min | 20 min | 35 min | 50 min | 65 min | 80 min | 95 min | 110 min | 125 min | 185 min | 245 min | Post Operative Monitoring | Baseline | 30min | 1 hr | 2 hr | 4 hr | 8 hr | 12 hr | 18 hr | 24 hr
次要结局
- 1. To assess postoperative rescue analgesic requirements in both groups.(2. To compare hemodynamic stability between the groups throughout the perioperative period.)
研究者
Mayank Pal Singh
All India Institute Of Medical Sciences, Bhopal