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临床试验/NCT02364934
NCT02364934Unknown不适用

Effect of Different Anesthetics on Pharmacokinetics and Pharmacodynamics of Rocuronium in Closed-Loop Muscle Relaxant Infusion System

Tianjin Medical University General Hospital0 个研究点目标入组 240 人开始时间: 2015年3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
入组人数
240
主要终点
Time to give additional rocuromium

研究概览

简要总结

To explore and compare the effects of propoful, sevoflurane, and a combination of both on the pharmacokinetics and pharmacodynamics of rocuronium.

To discover and confirm sex differences on the pharmacokinetics and pharmacodynamics of rocuronium.

To evaluate and examine aged people on the pharmacokinetics and pharmacodynamics of rocuronium.

详细描述

Rocuronium is a non-depolarizing neuromuscular blocking agent with intermediate duration of action and without significant cumulative properties, suitable for continuous infusion. This study was designed to determine the dose requirements for rocuronium, administered by continuous infusion to maintain a stable 90-99% T1 depression (depression of the first twitch in the train-of-four, TOF) in adult, elderly and different sex patients under sufentanil and propoful, sevoflurane, or propoful + sevoflurane anaesthesia.

Methods Two hundred and ten patients, ASA physical status group I and II undergoing elective surgical procedures were studied. Pateients with neuromuscular and metabolic diseases, morbid obesity or receiving medication known to influence neuromuscular transmission were excluded from the study.

Anaesthesia Patients will be assigned at random to receive propofuol, sevolurane or propoful+sevoflurane anaesthesia. All patients will induced with midazolam, 0.1 mg/kg, sufentnail, 0.5 μg/kg, etomidate, 0.3 mg/kg and rocuronium, 0.6 mg/kg. In the propoful group, anaesthesia will be continued with propoful and sufentanil. The doseage of propotul and sufentanil will be adjusted by the blood pressure and heart rate of the patients. In the sevoflurane group, anaesthesia will be continued with sevoflurane (2%) and sufentanil. The doseage of sufentanil will be adjusted by the blood pressure and heart rate of the patients. The doseage of propoful and sufentanil will be adjusted by the blood pressure and heart rate of the patients.

Heart rate, invasive blood pressure, pulse and core body temperature were monitored throughout the procedure. The core body temperature was main tained between 36°C and 37°C using a warming blanket. Positive pressure ventilation was used to maintain the end-tidal CO2 between 4.5 kPa and 5.5 kPa. The inspired and end-tidal concentrations of carbon dioxide and volatile anaesthestics were monitored by a multigas monitor.

Neuromuscular transmission was monitored by recording the electromyographic (EMG) activity of the adductor pollicis muscle resulting from the supra- maximal stimulation of the ulnar nerve with train-of- four (TOF), 2 Hz for 2 s, applied at 10-s intervals. The ulnar nerve was stimulated through surface electrodes applied at the wrist, using square-wave currents of 0.2 ms duration. Ten minutes were allowed for the stabilization of anaesthesia and the EMG tracing before the intubating dose of rocuronium, 0.6 mg/kg, was given by the anaesthesiologist.

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
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA physical status group I and II
  • elective surgical procedures
  • The subject has given written informed consent to participate

排除标准

  • Coronary heart disease, bronchial asthma, cardiac, lung, hepatic and renal insufficiency
  • Severe HBP, obesity (BMI>30)
  • Neuromuscular and metabolic diseases
  • Receiving medication known to influence neuromuscular transmission
  • Pregnancy, psychiatric disease
  • Allergy history
  • Inability to understand the Study Information Sheet and provide a written consent to take part in the study.

研究组 & 干预措施

Propofol

Propofol is intravenously administrated during anesthesia maintenance in patients (18-65 years old)

干预措施: Propofol (Drug)

Sevoflurane

Sevoflurane (inhalation) is administrated during anesthesia maintenance in patients (18-65 years old)

干预措施: Sevoflurane (Drug)

Propofol (elderly)

Propofol is intravenously administrated during anesthesia maintenance in patients (≥65 years old)

干预措施: Propofol (Drug)

Sevoflurane (elderly)

Sevoflurane (inhalation) is administrated during anesthesia maintenance in patients (≥65 years old)

干预措施: Sevoflurane (Drug)

Propofol (men)

Propofol is intravenously administrated during anesthesia maintenance in men (18-65 years old)

干预措施: Propofol (Drug)

Sevoflurane (men)

Sevoflurane (inhalation) is administrated during anesthesia maintenance in men (18-65 years old)

干预措施: Sevoflurane (Drug)

Propofol (women)

Propofol is intravenously administrated during anesthesia maintenance in women (18-65 years old)

干预措施: Propofol (Drug)

Sevoflurane (women)

Sevoflurane (inhalation) is administrated during anesthesia maintenance in women (18-65 years old)

干预措施: Sevoflurane (Drug)

结局指标

主要结局

Time to give additional rocuromium

时间窗: 24h

A personal computer, working in a closed-loop system with the Relaxograph and a syringe infusion pump was used to administer rocuronium at the rate necessary for a stable 90-99% block of the first twitch response (1%\<T1\<10%).

次要结局

  • Bispectral index(BIS)(24h)
  • Agitation score(24h)
  • Total dose of rocuronium(24h)
  • Time to spontaneous breathing recovery, eye opening, extubation(24h)

研究者

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

Donglai Yan

Chief

Tianjin Medical University General Hospital

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