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临床试验/NCT02927587
NCT02927587已完成不适用

Optimal TCI Regimen for Sedation of Elderly Undergoing Fiberoptic Bronchoscopy: A Prospective Randomized Controlled Trial.

The Second Affiliated Hospital of Dalian Medical University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2015年11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
70
试验地点
1
主要终点
the adverse events(apnea , hypotension or hypertension, heart rate, oxygen saturation ,any cardiac event, cough score)

研究概览

简要总结

Target-Controlled Infusion (TCI) of Propofol has been proved to be a safe agent for conscious sedation in flexible bronchoscopy (FB) .However, the target setting of "effect-site" concentration (Cet) of propofol is still unclear in the elderly population .The aim of this study was to compare two induction Cet of propofol in elderly patients undergoing flexible bronchoscopy.

详细描述

BACKGROUND:Bronchoscopy is nowadays a very common and widespread technique that allows the physician to proceed for both diagnostic and therapeutic interventions. The risks of this procedure are low and depend mostly on the health of the patient. In our study we only considered the elderly ( age > 65 years old) which makes the risks even higher.

Target-Controlled Infusion (TCI) of Propofol has been proved to be a safe agent for conscious sedation in flexible bronchoscopy (FB) due to its fast onset of action and rapid recovery time. By virtue of an aging population, the number of bronchoscopy performed will likely increase in the elderly patients , however, the target setting of "effect-site"concentration (Cet) of propofol is still unclear among this population.

The aim of this study was to compare two induction Cet of propofol in elderly patients undergoing flexible bronchoscopy.

METHODS: Seventy patients were randomly divided into 2 groups . All patients were of American Society of Anesthesiologists (ASA) physical status of I-III, aged more than 65 years old and between 45 and 100 kg in weight. The induction Cet was targeted respectively at 1 and 2 ug/ml. Upon reaching the modified observer's assessment of alertness/sedation(MOAA/S) score 0-3, the Cet was increased or reduced during the procedures and the Ce level was set for the maintenance of sedation. Induction time, diagnostic procedures as well as the occurrence of adverse events such as apnea , hypotension or hypertension, heart rate, oxygen saturation (SpO2) ,any cardiac event, cough score, frequency of adjustments of drug doses were recorded.

The patient will be monitored during the procedure with periodic blood pressure checks, respiratory rate, continuous electrocardiogram monitoring of heart and oxygen measurement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • body mass index < 30 in males or <28 in females
  • an ASA physical status I and III

排除标准

  • severe sleep apnoea syndrome (apnoea-hypopnea index > 40)
  • bradycardia
  • hypotension

研究组 & 干预措施

The induction Cet of propofol 1

Experimental

The induction Cet of propofol was targeted at 1 ug/ml.

干预措施: The induction Cet of propofol (Drug)

The induction Cet of propofol 2

Other

The induction Cet of propofol was targeted at 2 ug/ml.

干预措施: The induction Cet of propofol (Drug)

结局指标

主要结局

the adverse events(apnea , hypotension or hypertension, heart rate, oxygen saturation ,any cardiac event, cough score)

时间窗: 1 and 2 hours

Change from beginning of sedation to removal of bronchoscope

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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