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临床试验/NCT00513032
NCT00513032已完成不适用

Effects of Methylene Blue on Propofol Requirement During Anaesthesia Induction and Surgery

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1

研究概览

简要总结

We hypothesized that pre-treatment with methylene blue could potentiate the effects of general anaesthetic agents in patients undergoing parathyroidectomy

详细描述

Sample and study design The local ethics committee granted approval for this study and informed written consent will be obtained from all participants. We will study ASA grade I or II patients, aged between 45 and 73 years who were free from cardiovascular and pulmonary diseases. Patients with psychiatric disorders or drug abuse as well as those weighing 20% more or less than their ideal body weight will all be excluded.

The interventional group will consist of 11 patients scheduled for elective parathyroidectomy who will receive MB infusion (5mg.kg-1 in 250 ml 5% glucose-saline) approximately 60 min before anaesthesia induction. A further 11 patients scheduled for unilateral thyroid lobectomy without MB pre-treatment will be recruited as controls. They will present with normal thyroid tests and will carefully be selected in an attempt to match the intervention group on the basis of age, weight and sex. Both types of surgical procedures will be performed by the same surgical team.

Anaesthesia and surgery All patients will be premedicated with oral midazolam 7.5 mg and they will receive a loading dose of lactate-ringer solution (5 ml.kg-1) intravenously after arrival in the operating theatre. The standard anaesthetic monitoring will comprise non-invasive blood pressure, ECG, pulsed oxygen saturation and end-tidal carbon dioxide. Processed EEG parameters will be acquired with a BIS monitor, using surface electrodes, with impedance maintained at less than 5kΩ to ensure adequate signal quality. Raw EEG data from two channels (F7-CZ and F8-CZ) will be processed by company proprietary software and the BIS values (calculated for each 4-sec epoch) will be continuously displayed along with the trend line.

Propofol will be infused using a commercially available TCI system loaded with Schneider's 3-compartment pharmacokinetic model wherein the individual patient's age, height and weight will be programmed. The target effect-site concentration of propofol will be computed to yield a time to peak effect of 1.6 min, which has been confirmed clinically.

During anaesthesia induction, the patients will breath an air-oxygen mixture through a face mask. The target effect-site concentration of propofol will first be set at 0.5 ng.ml-1 and it will be increased by 0.2 ng.ml-1 every 2 min until the clinical endpoint will be achieved (loss of consciousness and unresponsiveness). Then, ventilation will be assisted manually and the trachea will be intubated after the intravenous administration of fentanyl (100 mcg) and rocuronium (0.7 mg.kg-1).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing parathyroidectomy or partial thyroidectomy

排除标准

  • Psychiatric disorders
  • Drug abuse
  • Weight 20% more or less than ideal body weight

研究组 & 干预措施

methylene blue

干预措施: methylene blue (Drug)

C

干预措施: methylene blue (Drug)

研究者

申办方类型
Other

研究点 (1)

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