Evaluation of the Impact of Adding Remifentanil to Propofol on the Conditions of the Diagnostic Panendoscopy of the Upper Airway Under General Anesthesia With Tubeless Spontaneous Ventilation.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- Proportion of patients presenting clinically acceptable conditions for the diagnostic panendoscopy of the upper airway
研究概览
简要总结
The most important considerations for the general anesthesia in diagnostic panendoscopy of the upper airway is the maintenance of a patient's airway for optimal surgical exposure, adequate ventilation and sufficient depth of anesthesia. Tubeless anesthestic techniques with preserved spontaneous ventilation and total intravenous administration of anesthetic drugs are widely use. Due to its pharmacological profile, propofol anesthesia is often considered as the gold standard for the anesthesia in the diagnostic panendoscopy. Previous studies suggested that adding remifentanil to propofol could improve the conditions for laryngoscopy and tracheal intubation.
The aim of this study is to assess the impact of propofol remifentanil general anesthesia compared to propofol general anesthesia on the conditions of the diagnostic panendoscopy of the upper airway.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Elective diagnostic panendoscopy of the upper airway
- •Age > 18 and < 80 years old
- •American Society of Anesthesiology (ASA) score equal to 1, 2, or 3 with a stable condition
- •Written inform consent
排除标准
- •Pregnancy or breastfeeding
- •Age < 18 years old or inability to give informed consent
- •Known anaphylaxis to remifentanil or propofol
- •Long term opioid use, drug abuse
- •Predictive criterion of impossible mask ventilation or intubation
- •Chronic respiratory failure requiring oxygen therapy
研究组 & 干预措施
Remifentanil
The general anesthesia during the diagnostic panendoscopy of the upper airway will associate the target controlled infusion of propofol (pharmacologic model of Schnider et al.) and of remifentanil (pharmacologic model of Minto et al.) in the remifentanil group.
The arm will be randomized prior to the beginning of the surgical procedure and blinded to the investigator and to the practitioner in charge of the patient.
Two milligrams of remifentanil will be diluted in 40 cc of sodium chloride 0,9% in a 50 ml syringe.
干预措施: Remifentanil (Drug)
结局指标
主要结局
Proportion of patients presenting clinically acceptable conditions for the diagnostic panendoscopy of the upper airway
时间窗: During the diagnostic panendoscopy of the upper airway
The assessment of the conditions for the diagnotic panendoscopy of the upper airway will be based on: (1) the conditions for the laryngoscopy ("excellent"=easy; "good"=fair; "poor"=difficult), (2) the position of the vocal cords ("excellent"=abducted; "good"=intermediate; "poor"=closed), (3) the movements of the vocal cords ("excellent"=none; "good"=moving; "poor"=closing), (4) the movement of the limbs ("excellent"=none; "good"=sight; "poor"=vigorous), (5) the cough ("excellent"=none; "good"=diaphragm; "poor"=sustained (\>10 s)). The conditions for the diagnostic panendoscopy will be considered as "excellent" when all variables will be excellent, as "good" when all variables will be either good or excellent and as "poor" when one or more variables will be graded as poor. Clinically acceptable conditions are defined as either good or excellent conditions.
次要结局
- DeltaHRmax(During the diagnostic panendoscopy)
- DeltaHRmin(During the diagnostic panendoscopy)
- DeltaMAPmin(During the diagnostic panendoscopy)
- DeltaMAPmax(During the diagnostic pandoscopy)
- Proportion of patients presenting at least one episode of moderate hypoxemia(During the diagnostic panendoscopy)
- Proportion of patients presenting at least one episode of severe hypoxemia(During the diagnostic panendoscopy)
- Proportion of patients requiring invasive mechanical ventilation(During the diagnostic panendoscopy)
- Proportion of patients presenting surgery complications(During the panendoscopy of the upper airway)