Intravenous Infusion Versus Intrathecal Injection of Magnesium Sulfate for Prevention of Postspinal Shivering During Lower Limb Fracture Surgery. A Randomized Comparative Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- incidence of postspinal shivering
研究概览
简要总结
Shivering is an unpleasant experience after spinal anesthesia. Shivering is defined as an involuntary, repetitive activity of skeletal muscles. The mechanisms of shivering in patients undergoing surgery are mainly intraoperative heat loss, increased sympathetic tone, pain, and systemic release of pyrogens. Spinal anesthesia significantly impairs the thermoregulation system by inhibiting tonic vasoconstriction, which plays a significant role in temperature regulation. Spinal anesthesia also causes redistribution of core heat from the trunk (below the block level) to the peripheral tissues. These two effects predispose patients to hypothermia and shivering. The median incidence of shivering related to regional anesthesia observed in a review of 21 studies is 64.4%. Shivering increases oxygen consumption, lactic acidosis, carbon dioxide production, and metabolic rate by up to 400%. Therefore, shivering may cause problems in patients with low cardiac and pulmonary reserves. The best way to avoid these intraoperative and postoperative shivering-induced increases in hemodynamic and metabolic demands is to prevent shivering in the first place. Although magnesium is among several pharmacological agents used for the treatment of shivering, its effects on prevention of shivering during central neuraxial blockade have not been evaluated to date. Henceforth, the aim of this study was to evaluate the effect of magnesiume on shivering during spinal anesthesia.
Aim:
to compare the efficacy of intravenous versus intrathecal magnesium sulphate for prevention of post spinal shivering in adult patients undergoing elective lower limb orthopedic surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 20-45 years old
- •Both genders
- •ASA I, II
排除标准
- •Patients with hemodynamic instability
- •cardiopulmonary
- •renal , liver disease
- •hypo or hyperthyroidism
- •cerebrovascular insufficiency
- •coagulation defects
- •those with psychiatric disorder
- •patients receiving vasoactive drugs or beta blockers
- •BMI > 35
- •allergic to study drug
- •height <160 cm or >190 cm
- •basal body temperature >38°C or <36°C
- •those who received blood transfusion or >2000 mL fluid intra-operatively
- •surgery duration > 3 hours
研究组 & 干预措施
Intrathecal Mg group
45 patients will receive 50 mg intrathecal MgSo4 added to 0.5% hyperbaric bupivacaine
干预措施: Magnesium Sulfate 1000 MG (Drug)
IV Mg infusion group
45 patients will receive IV magnesium sulfate 50 mg/kg in 100 mL isotonic saline over 20 min as a bolus then 2 mg/kg/h infusion using a separate infusion set after administering spinal anesthesia
干预措施: Magnesium Sulfate 1000 MG (Drug)
结局指标
主要结局
incidence of postspinal shivering
时间窗: up to 5 months
the efficacy of the use of MgSo4 IV infusion versus intrathecal injection in decreasing the incidence of postspinal shivering using Crossley and Mahajan scale which is 0, no shivering; 1, piloerection or peripheral vasoconstriction (cyanosis) but no visible shivering; 2, muscular activity in only one muscle group; 3, muscular activity in more than one muscle group but not generalized shivering; and 4, shivering involving the whole body
次要结局
未报告次要终点
研究者
Sherif Abdullah Mohamed
Lecturer of anesthesia
Cairo University