The Optimal Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy：a Prospective Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Induction Time, Time Period That Will be Required for Conscious Level to Reach OAAS-3
研究概览
简要总结
Alfentanil (Alf) is used in combination with Propofol (Pro) in fiber-bronchoscopy and in many other conscious sedation procedures. Alf and Pro have the characteristic of rapid anesthetic onset and quick recovery, synergic sedative effect and unwanted side effects too. However, the amount of Alf needed in combination with Pro for induction and the timing of administration was no standardized. The investigators designed this study to evaluate the optimal regimen, dose and timing of Alf in Target-Controlled infusion (TCI) of Pro for flexible bronchoscopy sedation, and also to evaluate the influence of variable regimen of Alf and Pro on hypoxemia, hypotension, cough severity, and Pro injection related pain.
详细描述
Alfentanil (Alf) is used in combination with Propofol (Pro) in fiber-bronchoscopy and in many other conscious sedation procedures. Alf and Pro have the characteristic of rapid anesthetic onset and quick recovery, synergic sedative effect and unwanted side effects too. However, the amount of Alf needed in combination with Pro for induction and the timing of administration was no standardized. The investigators designed this study to evaluate the optimal regimen, dose and timing of Alf in Target-Controlled infusion (TCI) of Pro for flexible bronchoscopy sedation.
Method: patients will be enrolled and assigned randomly into five groups. In group 1, normal saline two minutes before and Alf 2.5μg/kg before Pro were given; In group 2, normal saline two minutes before and Alf 5μg/kg before Pro were given; In group 3, Alf 2.5μg/kg two minutes before and normal saline before Pro were given; In group 4: Alf 5μg/kg two minutes before and normal saline before Pro were given; in group 5, normal saline two minutes and before Pro were given.
Concentration of effect site to loss of consciousness (LOC), dose of Pro to LOC, and induction time of variable regimen, as well as hypoxemia, hypotension, cough severity, and Pro injection related pain will be recorded and analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who required elective sedative bronchoscopy
排除标准
- •any physical, psychiatric, social problem that avoid from conscious level evaluation,
- •hypersensitivity or allergy to Propofol, Alfentanil
- •severe chronic obstructive pulmonary disease (forced expiratory volume in 1 s ,50% of predicted value, or requirement for oxygen therapy)
- •unstable haemodynamic status (defined as a heart rate < 60 or ≧ 120 bpm and/or
- •a systolic blood pressure (SBP) < 100 or ≧ 180 mmHg)
- •predictable difficult upper airways (Mallampati classification score of IV)
- •severe obstructive sleep apnea with apnea hypopnea index (AHI) > 45
- •Body mass index (BMI) more than 42 in male and 35 in female
- •renal insufficiency
- •liver cirrhosis
研究组 & 干预措施
Group1
Alfentanil 2.5μg/kg before propofol
干预措施: Alfentanil (Drug)
Group1
Alfentanil 2.5μg/kg before propofol
干预措施: Normal saline (Drug)
Group1
Alfentanil 2.5μg/kg before propofol
干预措施: Targeted controlled infusion (Device)
Group1
Alfentanil 2.5μg/kg before propofol
干预措施: Propofol (Drug)
Group2
Alfentanil 5μg/kg before propofol
干预措施: Alfentanil (Drug)
Group2
Alfentanil 5μg/kg before propofol
干预措施: Normal saline (Drug)
Group2
Alfentanil 5μg/kg before propofol
干预措施: Targeted controlled infusion (Device)
Group2
Alfentanil 5μg/kg before propofol
干预措施: Propofol (Drug)
Group 3
Alfentanil 2.5μg/kg two minutes before propofol
干预措施: Alfentanil (Drug)
Group 3
Alfentanil 2.5μg/kg two minutes before propofol
干预措施: Normal saline (Drug)
Group 3
Alfentanil 2.5μg/kg two minutes before propofol
干预措施: Targeted controlled infusion (Device)
Group 3
Alfentanil 2.5μg/kg two minutes before propofol
干预措施: Propofol (Drug)
Group 4
Alfentanil 5μg/kg two minutes before propofol
干预措施: Alfentanil (Drug)
Group 4
Alfentanil 5μg/kg two minutes before propofol
干预措施: Normal saline (Drug)
Group 4
Alfentanil 5μg/kg two minutes before propofol
干预措施: Targeted controlled infusion (Device)
Group 4
Alfentanil 5μg/kg two minutes before propofol
干预措施: Propofol (Drug)
Group 5 Control
propofol alone
干预措施: Normal saline (Drug)
Group 5 Control
propofol alone
干预措施: Targeted controlled infusion (Device)
Group 5 Control
propofol alone
干预措施: Propofol (Drug)
结局指标
主要结局
Induction Time, Time Period That Will be Required for Conscious Level to Reach OAAS-3
时间窗: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours
After the administration of Alfentanil and Propofol, the time period required to reach conscious level OAAS-3 will be recorded.
Propofol Dose Needed to Reach Conscious Level OAAS-3
时间窗: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours
After the administration of Alfentanil and Propofol, the Propofol dose needed to reach conscious level of observer assessment of alertness and sedation scale 3 (OAAS-3) will be recorded.
Effect Site Concentration When Conscious Level Reaches OAAS-3
时间窗: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours
After the administration of alfentanil and propofol, the effect site concentration was recorded at the time when the consciousness level reaches observer assessment of alertness and sedation scale 3 (OAAS-3). The effect site concentration is the concentration of drug propofol in brain calculated by TCI using Schnider model.
次要结局
- Hypotension(All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours)
- Hypoxemia(All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours)
研究者
Chung-Hsing, Hsieh
Chief of Medical Intensive Care Unit, Department of Internal Medicine, Chang-Gung Memorial Hospital, Taipei
Chang Gung Memorial Hospital