Comparison of Intubation Conditions After Induction With Propofol Associated With a Dose of Remifentanil or Sufentanil in Surgical Tooth Extraction.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Scandinavian Scale of Intubation Conditions (from Viby-Mogensen). The comparison will be made on the percentage of obtaining excellent intubation conditions.
研究概览
简要总结
The main objective is the comparison of intubation conditions after anesthetic induction bolus of propofol-sufentanil when compared to injection of propofol-remifentanil in patients undergoing surgery for tooth extraction.
Intubation without myorelaxant with propofol and sufentanil is classic but less efficient than induction with curare on achieving perfect intubation conditions. The use of a protocol without curare is sometimes justified for short gestures or when you want to avoid allergia. Remifentanil often provides excellent intubation conditions without myorelaxant. However, remifentanil was never compared to sufentanil in terms of intubating conditions without muscle relaxant.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients 18 to 60 years
- •American Society of Anesthesiology (ASA) 1 or 2
- •scheduled for surgical tooth extraction under general anesthesia with intubation
- •signed consent form
排除标准
- •criterion of difficult ventilation or intubation
- •chronic alcoholism or opiate use
- •beta-blockers or calcium channel blockers treatment
- •allergy to paracetamol or ketoprofen
- •patient under protection of justice
研究组 & 干预措施
Remifentanyl- sufentanil placebo
3 mg/kg of propofol combined with 3 µg/kg of remifentanil
干预措施: Remifentanyl - sufentanil placebo (Drug)
Sufentanil - remifentanyl placebo
3 mg/kg of propofol combined with 0.3 mg/kg of sufentanil
干预措施: Sufentanil - remifentanyl placebo (Drug)
结局指标
主要结局
Scandinavian Scale of Intubation Conditions (from Viby-Mogensen). The comparison will be made on the percentage of obtaining excellent intubation conditions.
时间窗: This outcome measure is assessed at day 1 during the per-anesthetic period.
次要结局
- percentage of patient with a decrease of over 20% in Mean Arterial Pressure (MAP) or Heart Rate (HR)(This outcome measure is assessed at day 1 during the per-anesthesic period and the monitoring period in PACU.)
- breath - hold time - time to extubation, time to Aldrete score of 10 in PostAnesthesia Care Unit (PACU)(This outcome measure is assessed at day 1 during the per-anesthesic period and the monitoring period in PACU.)
- difficult intubating scale (Adnet et al. Anesthesiology. 99)(This outcome measure is assessed at day 1 during the per-anesthesic period and the monitoring period in PACU.)