Etomidate With Meperidine vs Midazolam With Meperidine for Sedation During Endodscopic Retrograde Cholangiopancreatogram (ERCP)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Number of Intervention
研究概览
简要总结
Recently up-coming drug, etomidate which is a modulator of GABA(gamma-Aminobutyric acid)-A receptor has been known that it maintains the appropriate sedative levels and affects little effects on respiratory system.
The investigators are now trying to investigate that etomidate with meperidine combination regimen is superior to the midazolam with meperidine more effective and less harm on sedation during the ERCP procedure.
详细描述
ERCP (Endoscopic retrograde cholangiopancreatogram) is an uncomfortable and time-consuming procedure compared to other endoscopic procedures. Most ERCP procedure had been performed in sedation using tranquilizers and pain-killers.
Until recently, midazolam and opioid combination regimen recognized as a standard therapy is widely used, but the sedative effect is insufficient and intermittent paradoxical reaction has been questioned. Another drug, such as propofol, has been known that the sedative effect is superior one of the midazolam but disappointed due to narrow therapeutic range of respiratory distress and absence of antagonist. Meanwhile, recently up-coming drug, etomidate which is a modulator of GABA-A receptor has been known that it maintains the appropriate sedative levels and affects little effects on respiratory system.
For these advantages, this short acting sedative drug has been widely used in the emergency room during minor operation and in the operation room for induction. However, research on the efficacy during ERCP was not yet published.
In this regards, the purpose of the investigators study is to prove the efficacy of etomidate for sedation and to establish new evidence based sedation guidelines during ERCP procedure.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who are scheduled diagnositic or therapeutic ERCP.
- •Age : more than 20 and less than 90 years old
- •ASA(American Society of Anesthesiologists) classificiation : I, II, III
排除标准
- •Patients following
- •Refuse to be enrolled
- •ASA American Society of Anesthesiologists)classification IV, V
- •Breast feeder
- •The mentally ill
- •Drug abuser
- •Hypersensitivity to sedative or opioids
- •Alcohol intoxication or dependency
- •Body mass index (BMI) 36kg/m2 or more
- •Unstable vital sign
- •tachypnea, respiration rate more than 25/min or less than 10/min
- •Oxygen saturation : 90% or less
- •Systolic blood pressure : less than 90 mmHg or more than 180 mmHg
- •Diastolic blood pressure : less than 50 mmHg or more than 100 mmHg
- •Heart rate : more than 120 beat/min or less than 50 beat/min.
研究组 & 干预措施
Etomidate
This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.
干预措施: Etomidate (Drug)
Etomidate
This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.
干预措施: Meperidine (Drug)
Midazolam
This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.
干预措施: Midazolam (Drug)
Midazolam
This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.
干预措施: Meperidine (Drug)
结局指标
主要结局
Number of Intervention
时间窗: Throughout the whole ERCP procedure
The frequency of intervention which was defined as any restraint of the patient's head, arms, or legs if they became agitated, or if patient movement was not controlled with verbal instruction from the endoscopist during the whole intraoperative phases.
次要结局
- Event of Hypoxia(Every 5min in Preoperative, intraoperative phase and 15 min in Recovery phase)
研究者
Byung Hyo Cha, MD
Director of Endoscopy clinic, Digestive Disease Center, Department of Internal Medicine
Cheju Halla General Hospital