The Effect of Alfentanil on the Lower Esophageal Sphincter During Anesthesia Induction - a Study in Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Changes in barrierpressure (in mmHg) in the area of the lower esophageal sphincter.
研究概览
简要总结
This study evaluates the effects of adding an opioid (alfentanil) during anesthesia induction with respect to the barrierpressure in the esophagogastric junction.
The secondary aim was to investigate whether the effect of cricoid pressure influences the barrierpressure.
详细描述
During anesthesia induction and tracheal intubation one major concern is to avoid passive regurgitation of gastric content and aspiration.
The lower esophageal sphincter is a muscle located at the distal end of the esophagus. It plays an important role in creating a barrier between the stomach and the esophagus. The term "barrierpressure" is defined as the pressure difference between the lower esophageal sphincter pressure and the pressure in the stomach (intragastric pressure).
There are studies showing that opioids given iv/im, in the vein or in the muscle, may decrease the pressure in the lower esophageal sphincter and hereby increase the risk of aspiration.
Nevertheless,other studies shows that opioids are still frequently given to patients during anesthesia induction. This is done in order to prevent the cardiovascular response to (the painful) intubation which can often be seen as an equally high risk for the patient as the risk of aspiration.
In light of the above description, the investigators are planning a study in volunteers with the primary aim of investigating the effects of an opioid (alfentanil) on the pressures in the lower esophageal sphincter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer 18-40 years old
- •Informed,signed and dated consent
排除标准
- •Pharyngoesophageal dysfunction
- •Gastro/intestinal-,cardiovascular-,lung- or neurologic disease
- •Ongoing medication
- •Allergy to alfentanil, propofol, soya or peanuts
- •Pregnancy or breast-feeding
- •Participation in other clinical trial -ongoing or during last 30 days.
研究组 & 干预措施
opioid
Preoxygenation for 5 min. Injection of opioid (alfentanil 20 mikrogr/kg iv) after 2 min:Injection of induction drug(propofol 2-2.5mg/kg) after anesthesia induction: Application of cricoid pressure for 15 sec.
干预措施: alfentanil (Drug)
placebo
Preoxygenation for 5 min. Injection of saline iv. after 2 min:Injection of induction drug(propofol 2-2.5mg/kg) after anesthesia induction: Application of cricoid pressure for 15 sec.
干预措施: saline (Drug)
结局指标
主要结局
Changes in barrierpressure (in mmHg) in the area of the lower esophageal sphincter.
时间窗: 1 min after the application of the induction agent (propofol)
Pressure variations in the lower esophageal sphincter will be measured continuously during the whole study. Registrations will be saved in the computer-software. Predetermined time points will be marked on the registrations for later evaluation.
次要结局
- Changes in barrierpressure (in mmHg) in the area of the lower esophageal sphincter.(1min after the opioid/placebo injection)