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临床试验/NCT04194151
NCT04194151已完成4 期

Impact of Propofol Dose Reduction in Relation to the Time Since Administration of Fentanyl During Anesthesia Induction

Hospital Central de la Defensa Gómez Ulla1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2017年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
192
试验地点
1
主要终点
Systolic Blood Pressure Variation

研究概览

简要总结

Objective: Determine if, by reducing the dose of propofol and increasing the time elapsed between fentanyl and propofol administration, hemodynamic response is improved.

Methods: Patients were randomized into time groups (2 and 1 minute) and each subdivided into dose groups (1, 1.5 and 2 mg kg-1) obtaining six time-dose groups. After receiving 2 μg kg-1 of fentanyl, propofol was administered after the predetermined time. Time to hypnosis (BIS<60) and hemodynamic parameters at pre-induction, pre-intubation and postintubation were registered.

详细描述

A minimum of 162 patients were required, considering an expected Mean Difference of 5 with expected Standard Deviation of 22, confidence level of 95% and power of 80%. Estimating a possible loss of 15%, it was raised to 192. Consecutive identification numbers were assigned and the sample was randomized in six groups of 32 patients according to time and dose of propofol.

Pre-oxygenation was performed until the expired oxygen fraction exceeded 80% and 2 µg/kg of intravenous fentanyl were administered. Depending on the study group, 1 or 2 minutes were allowed to pass and 1, 1.5 or 2 mg/kg of propofol were supplied (prior administration of intravenous lidocaine 0.5 mg/kg). The time in which the BIS dropped below 60 was recorded. If it did not reach that level after two minutes or when it exceeded it but then rose above 60 again, an extra dose of propofol of 0.5 mg/kg was administered. Muscle relaxation was performed with rocuronium 0.6 mg/kg. The patient was manually ventilated until endotracheal intubation was performed by the same experienced anaesthesiologist and connected to mechanical ventilation.

Data were collected manually. Statistical analysis was performed using SPSS ver. 22. Inferential statistics were performed using t-test for quantitative variables, chi-square for qualitative and ANOVA for qualitative and quantitative comparisons. Non-parametric statistical tests were used when necessary. Confidence intervals were estimated at a level of 95% and a P value of <.05 was considered statistically significant.

研究设计

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

盲法说明

aleatory assignation, time measured by nurses, drugs administrated by principal investigator

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

  • Adults who required general anesthesia
  • General anesthesia with endotracheal intubation (no supraglottic devices)
  • Signed informed consent
  • Non-cardiac surgery
  • Same anesthesiologist

排除标准

  • Hemodynamic instability (systolic BP < 90 mmHg with clinical signs of low cardiac output: impaired consciousness, diuresis <0.5 ml/kg/h, central venous saturation <60% with normal arterial saturation or lactate >3 mmol/l)
  • Increased risk of bronchoaspiration (absence of fasting, stomach retention, intestinal obstruction, pregnancy, etc.)
  • Suspected difficult airway
  • Known allergy to anesthetic drugs

研究组 & 干预措施

2 minute - 2 mg/kg group

Active Comparator

2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 2 mg/kg of propofol

干预措施: Propofol Injection (Drug)

2 minute - 1,5 mg/kg group

Active Comparator

2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1,5 mg/kg of propofol

干预措施: Propofol Injection (Drug)

2 minute - 1 mg/kg group

Active Comparator

2 mcg/kg of fentanyl administrated intravenously. wait for 2 minutes to inject 1 mg/kg of propofol

干预措施: Propofol Injection (Drug)

1 minute - 2 mg/kg group

Active Comparator

2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 2 mg/kg of propofol

干预措施: Propofol Injection (Drug)

1 minute - 1,5 mg/kg group

Active Comparator

2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1,5 mg/kg of propofol

干预措施: Propofol Injection (Drug)

1 minute - 1 mg/kg group

Active Comparator

2 mcg/kg of fentanyl administrated intravenously. wait for 1 minute to inject 1 mg/kg of propofol

干预措施: Propofol Injection (Drug)

结局指标

主要结局

Systolic Blood Pressure Variation

时间窗: Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned

Non-invasive systolic blood pressure change (%) at baseline, pre-intubation and postintubation. Positive results mean percentage reduction in SBP between the studied moments. Negative results mean percentage increase in SBP between the studied moments.

Heart Rate Variation

时间窗: Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned

Heart rate change (%) registered at baseline, pre-intubation and postintubation. Positive results mean percentage reduction in HR between the studied moments. Negative results mean percentage increase in HR between the studied moments.

Systolic Blood Pressure Variation in Elderly (>55y)

时间窗: Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned

Non-invasive SBP change (%) in patients \> 55 years at baseline, pre-intubation and postintubation. Positive results mean percentage reduction in SBP between the studied moments. Negative results mean percentage increase in SBP between the studied moments.

次要结局

  • Number of Patients Who Needed Vasoactive Drug(1 minute after intubation)
  • Time to Hypnosis(After administration of propofol, time is measured in seconds until BIS values are less than 60)

研究者

发起方
Hospital Central de la Defensa Gómez Ulla
申办方类型
Other
责任方
Principal Investigator
主要研究者

paula agostina vullo

Sponsor-Investigator

Hospital Central de la Defensa Gómez Ulla

研究点 (1)

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