跳至主要内容
临床试验/NCT01494220
NCT01494220已完成不适用

Validation of the Bispectral Index Monitor During Living Donor Liver Transplantation

Mansoura University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Intraoperative blood loss

研究概览

简要总结

Bispectral index (BIS) monitoring during living donor liver transplantation (LDLT) may be influenced with several factors rather than the depth of anesthesia such as bradycardia, hypotension, hypothermia, and mixed venous oxygen saturation (SvO2). The investigators tested the validity and the independent factors which may alter of BIS readings during LDLT.

Up to the investigators best knowledge, the independent predictors for BIS monitoring were not identified yet during the three phases of liver transplantation.

详细描述

Forty two American Society of Anesthesiologists physical class III-IV patients aged 20-50 years with severe liver dysfunction (Child-Pugh Class C) due to liver cirrhosis undergoing living donor liver transplantation in the Mansoura University Liver Transplantation Program from 2007 to 2010 were included in this prospective, observational study after obtaining approval of the local ethical committee and an informed written consent from all participants. The etiology of liver cirrhosis was hepatitis C, Budd Chiari syndrome, hepatocellular carcinoma and autoimmune in all patients.

Anesthetic technique was standardized for all patients. All patients received preoperative intravenous 40 mg of pantoprazole. Patients were monitored with three leads electrocardiography, pulse oximeter, and noninvasive blood pressure. BIS recording electrodes (Aspect Medical Systems. Inc., One Upland Road, Norwood, MA 02062 USA) were applied to the forehead of each patient according to the manufacturer recommendations. The BIS monitor was masked with opaque sheet and BIS data was recorded prior to induction of general anesthesia then continued throughout the procedure. All information obtained from the BIS monitor was continuously downloaded to a computer for offline analysis. The patient's management was not guided by the changes in BIS readings. Before induction of anesthesia, all patients were premedicated with 1-2 mg of intravenous midazolam.

Independent anesthetists, who were not involved in the collection and analysis of the patient's data, provided the perioperative anesthetic management. After preoxygenation, anesthesia was induced with lidocaine 0.75 mg/kg, propofol 1.5-2.0 mg/kg and fentanyl 2µg/kg. Rocuronium 1-1.2 mg/kg was given to suppress the first response on the train-of-four (TOF) stimulations of the ulnar nerve. After tracheal intubation, the lungs were ventilated with an inspired fraction of oxygen (FiO2) of 0.4 to maintain an arterial carbon dioxide tension at 35-45 mm Hg and monitoring of end-tidal carbon dioxide and sevoflurane concentration, direct arterial pressure monitoring through a radial artery catheter and a tympanic membrane temperature were implemented.

A 7.5 Fr continuous thermodilution fiberoptic pulmonary artery catheter (CCO/SvO2) Edwards Life Science, Irvine, CA, USA) was floated through the right internal jugular vein to the right pulmonary artery using waveform and fluoroscopic guidance to measure cardiac output using Angstrom AS5 Monitor (Datex - Ohmeda AS5, Microvitec Display LTD, Bolling Road, Bradford, UK). The final position was confirmed by fluoroscopy and when PAOP less than pulmonary artery diastolic pressure (PADP).

Anesthesia was maintained with 0.5-1.5 minimum alveolar concentration (MAC) of sevoflurane and continuous intravenous infusion of fentanyl (1-3 µg/kg/h) titrated to maintain the mean arterial blood pressure (MAP) and heart rate (HR) within 20% of their baseline values. Rocuronium 0.1-0.3 mg/kg/h was used to maintain suppression of the second twitch in the TOF.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical class III-IV
  • aged 20-50 years
  • severe liver dysfunction
  • Child-Pugh Class C
  • liver cirrhosis

排除标准

  • preexisting significant neuropsychiatric
  • cardiac diseases
  • pulmonary diseases
  • renal diseases
  • neuromuscular diseases
  • electrolyte disorders
  • body mass index greater than 35 kg/m2
  • pregnancy
  • use of antipsychotics
  • use of antidepressants
  • alcohol abuse
  • drug abuse
  • previous transplantation
  • those with hepatic encephalopathy
  • recent cognitive dysfunction during the past three months
  • fulminant hepatic failure
  • hepato-pulmonary syndrome
  • pulmonary hypertension

结局指标

主要结局

Intraoperative blood loss

时间窗: up to 1 hr after surgery

Intraoperative blood loss

Changes from Baseline in hemodynamic variables

时间窗: 30 min during hepatectomy, 30 min during anhepatic, 30 min during neohepatic phases

Hemodynamic changes

Changes from Baseline in Temperature variables

时间窗: 30 min during hepatectomy, 30 min during anhepatic, 30 min during neohepatic phases

Temperature

Changes in blood gases variables from baseline

时间窗: 30 min during hepatectomy, 30 min during anhepatic, 30 min during neohepatic phases

Blood gases

次要结局

  • postoperative liver function tests(up to 6 hrs after surgery)
  • postoperative coagulation factors(up to 6 hrs after surgery)
  • 3-months mortality(up to 3 months after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed R El Tahan

Dr

Mansoura University

研究点 (1)

Loading locations...

相似试验