Comparative Study Between Continuous Spinal Anesthesia Versus General Anesthesia in Patients With Sepsis
概览
- 阶段
- 4 期
- 干预措施
- Continuous spinal anesthesia
- 疾病 / 适应症
- Sepsis
- 发起方
- Mahmoud Rashad Ahmed
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Mortality rate
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
The anesthetic efficacy and safety of continuous spinal anesthesia and comparing it with general anesthesia technique in sepsis diagnosed patient.
详细描述
Hemodynamic instability due to high block largely limits the use of conventional dose spinal anesthesia in high-risk septic patients. Hypotension is more common, and also more hazardous, in septic patients, as they may have decreased physiological reserve and compromised blood supply to various vital organs. A smaller dose of local anesthetic reduces the severity and incidence of hypotension during spinal anesthesia.
研究者
Mahmoud Rashad Ahmed
Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine
Tanta University
入排标准
入选标准
- •Patients over 21 years old
- •American Society of Anesthesiologists (III, IV) diagnosed with sepsis (Sequential Organ Failure Assessment (SOFA) score ≥ 7)
- •Hemodynamically stable and not on vasopressor due to lower limb pathology candidate for spinal anesthesia to drain source of infection.
排除标准
- •Patients with known hypersensitivity to local anesthesia.
- •Infection at the site of injection.
- •Coagulopathy.
- •Septic shock.
- •Increase of intracranial pressure.
- •Severe deformity of the spinal column.
研究组 & 干预措施
Continuous spinal anesthesia
Preservative free 0.5% Hyperbaric bupivacaine (AstraZeneca) 5mg + 25mcg fentanyl for the initial dose will be followed by top up doses of 2.5 mg boluses of 0.5% Hyperbaric bupivacaine every 10 minutes until the desired block height is obtained considering patient hemodynamics. Norepinephrine starting dose 0.01 micg/kg/min will be ready for both groups if needed (main arterial pressure \< 70 or main arterial pressure decreased more than 20% of preoperative value). The infusion will be through a wide bore Intravenous line. The dose will be titrated up or down according to the patient hemodynamics.
干预措施: Continuous spinal anesthesia
General anesthesia
After establishing of ASA monitoring, a wide bore cannula (18Gague) will be inserted. Induction will be done by fentanyl (2 mcg/kg), titrating dose. of propofol according to patient hemodynamic response and atracurium (0.5 mg/kg) to facilitate tracheal intubation maintaining End tidal Co2 between 30-40 mmHg.
干预措施: General anesthesia
结局指标
主要结局
Mortality rate
时间窗: 28 Days postoperative
Patients' mortality during the first 28 day after surgery
次要结局
- Changes of Heart Rate(UP to 2 hours postoperative)
- Changes of Invasive Blood Pressure(UP to 2 hours postoperative)