Perioperative Effect of Desflurane Versus Total Intravenous Anesthesia With Propofol on Hemostasis Guided by Thromboelastometry in Splenectomy With Liver Cirrhosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- maximum clot firmness (MCF)
研究概览
简要总结
The aim of this prospective randomized study is to evaluate the perioperative effects of inhalational anesthesia (desflurane) and intravenous anesthesia (propofol) on hemostasis in patients undergoing splenectomy with liver cirrhosis guided by the new technology (ROTEM) and the traditional laboratory hemostatic markers.
详细描述
After obtaining approval from the Institutional Research Ethics Committee and informed written consent, thirty adult patients aged 25- 55 years of either sex, American Society of Anesthesiologists (ASA) class II- III (Child A) suffering from cytopenia scheduled for elective splenectomy will be recruited. Pancytopenia is defined as anemia (hemoglobin < 13.5 g/dL-male; <12 g/dL-female); leucopenia (total leukocyte count < 4,000/mm3) and thrombocytopenia (platelet count < 150,000/mm3). Child B and C, Hb < 10 g/dL platelet count < 50,000/mm3, White Blood Cells (WBCs) < 2,000/mm3, prothrombin time [PT] > 16 s and INR > 1.7, extremes of age, obese patients (body mass index >35 kg m-2), and those using oral anticoagulants, other antithrombotic drugs, or oral contraceptives, will be excluded from the study.
All patients will be premedicated with 0.05 mg kg-1 i.v midazolam half an hour before operation. In the operating room, continuous pulse oximetry, electrocardiogram, non-invasive arterial blood pressure, PECO2, end-tidal anesthetic agent, neuromuscular monitoring, core temperature (Infinity Kappa, Dräger, Lübeck, Germany) and hourly urine output will be monitored throughout the operation. Depth of anesthesia will be monitored by using Bispectral index (BIS). All IV fluids will be warmed, and a warm air blanket (Bair Hugger) will be applied to every patient.
Thirty eligible patients will be allocated randomly to one of two equal groups (15 patients each) according to a computer generated randomization list: group D; maintenance of anesthesia with inhaled desflurane at 1 minimum alveolar concentration (MAC); group P, maintenance of anesthesia with target-controlled infusion (TCI) propofol with a target plasma concentration of propofol between 2 and 5 µg ml-1. The concentration of volatile anesthetics or the rate of infusion of injected anesthetics will be titrated to maintain the BIS numerical value between 40-50.
Anesthesia will be induced in both groups using i.v. fentanyl 1.5- 2 µg kg-1 and propofol 2- 2.5 mg kg-1. Atracurium 0.5 mg kg-1 will be administered for neuromuscular block and continued according to the response to train-of-four peripheral nerve stimulation. After intubation, patients will be mechanically ventilated with 30% oxygen in air throughout surgery using a low flow system (1L min-1) to adjust an end-tidal carbon dioxide (PECO2) between 30- 35 mmHg. Acetated Ringer's solution will be given as a preload and maintenance at a rate of 5-7 ml kg-1 h-1. Patients' systolic arterial pressures will be maintained at 100 mmHg or 70% of the preoperative value, whichever is higher. Hypotension will be treated with i.v. crystalloid fluid loading or intravenous boluses of ephedrine as appropriate. No colloid transfusion will be allowed. Transfusions of red blood cells will be used to maintain hemoglobin levels equal to or above 8 g dl-1. Platelets or fresh frozen plasma will be infused only when indicated by ROTEM. At the end of surgery, neuromuscular blockade will be antagonized with 0.05 mg kg-1 neostigmine and 0.02 mg kg-1 atropine. Postoperative analgesia was provided by intravenous infusion of 1 gm acetaminophen and IV meperidine 1 mg kg-1 every 12 hours. Patients are given an anti-emetic ondansetron 4 mg postoperatively.
Blood Sampling:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ASA physical status II and III.
- •Age between 22-55 years.
- •Child A suffering from pancytopenia.
- •Type of surgery: splenectomy
排除标准
- •Patients using oral anticoagulants
- •Patients using antithrombotic drugs
- •Patients using non steroidal anti-inflammatory drugs
- •Patients using oral contraceptives
- •Age less than 25 or more than 55 years
- •Obese patients (body mass index >35 kg m-2)
- •Pregnancy and lactation
研究组 & 干预措施
Desflurane
Desflurane at 1 MAC and
干预措施: Desflurane (Drug)
propofol
propofol TCI (target controlled infusion) infusion of to keep a target plasma concentration between 2 and 5 µg ml-1
干预措施: Propofol (Drug)
结局指标
主要结局
maximum clot firmness (MCF)
时间窗: Up to 1 month
Ultimate strength and stability of the fibrin clot measured by ROTEM.
次要结局
- clotting time CT(Up to 1 month)
- clot formation time; CFT(Up to 1 month)
- D dimer(Up to 1 month)
- Platelet count(Up to 1 month)
- sP-selectin(Pre-operative, after ligation of splenic artery, immediate post-operative, 24 hours and three days after operation)
- Prothrombin Time(Pre-operative, after ligation of splenic artery, immediate post-operative, 24 hours and three days after operation)
- International Normalized Ratio (INR)(Pre-operative, after ligation of splenic artery, immediate post-operative, 24 hours and three days after operation)
- Fibrinogen Level(Pre-operative, after ligation of splenic artery, immediate post-operative, 24 hours and three days after operation)
- D-Dimer(Pre-operative, after ligation of splenic artery, immediate post-operative, 24 hours and three days after operation)
研究者
Yasser Mostafa Samhan
Professor of Anesthesia
Theodor Bilharz Research Institute
