Midazolam With Meperidine and Dexmedetomidine vs Midazolam With Meperidine for Sedation During ERCP
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Level of sedation
研究概览
简要总结
Endoscopic retrograde cholangiopancreatography (ERCP) takes a longer time and is more complex to perform than the other parallel procedures, causing discomfort to patients. It is commonly performed under sedation endoscopy. Until recently, the combination administration of midazolam and opioid has been widely used as standard therapy due to its superior sedation effect compared to the other sedation agents. Midazolam, however, has problems, such as an insufficient sedation effect and an intermittent paradoxical response.
Unlike midazolam, propofol has no antagonist and may cause problems such as respiratory depression, and has a narrow therapeutic range for the sedation effect, consequently requiring supervision by experienced experts, although it has a better sedation effect than midazolam. Due to these disadvantages, propofol is clinically less useful than midazolam.
Meanwhile, dexmedetomidine, a selective α2 adrenergic agonist, is known to maintain the proper level of sedation and has a weak influence on respiratory depression. Recent studies have shown positive results with dexmedetomidine in relation with the sedation effect for surgery patients under local anesthesia or in intensive care units.
As such, extensive studies are being conducted on the use of dexmedetomidine in endoscopic procedures due to the increased attention to dexmedetomidine. This notwithstanding, the clinical usefulness of dexmedetomidine is still debatable. In particular, studies on the use of dexmedetomidine for ERCP are very rare.
Given the recent idea that dexmedetomidine may exert a synergistic effect in combination with midazolam, these authors endeavored to prospectively compare and analyze the sedation effect and adverse events, including respiratory depression, of the combination therapy of midazolam and meperidine, both of which have been widely used in patients undergoing ERCP, and of the combination therapy of midazolam, meperidine, and dexmedetomidine.
The small-scale comparative study on the combination administration of propofol and fentanyl, which has a high risk of causing complications, and on the single administration of dexmedetomidine is the only study on the sedation effect of dexmedetomidine in the ERCP procedure that has yet been conducted; there has been no study that investigated the effect of the combination administration of dexmedetomidine and other drugs in the ERCP procedure. This study is thus expected to contribute to the development of guidelines on sedation in the ERCP procedure.
详细描述
Compared with upper gastrointestinal endoscopy, endoscopic retrograde cholangiopancreatography (ERCP) takes a longer time to perform and causes more discomfort to patients. In ERCP, benzodiazepine alone or in combination with opioid is commonly used for pain control and sedation.
Of the various benzodiazepine drugs, midazolam, which is water-soluble, has been shown to act faster and to be better in terms of anterograde amnesia and its sedation effect than other drugs. As midazolam has a suitable antagonist (flumazenil), prompt measures can be taken in case of such situations as hypopnea.
As midazolam was reported to increase the sedation effect and the level of satisfaction of patients when used in combination with opioid (meperidine), a combination of midazolam and meperidine has been the most widely used regimen so far. The American Society for Gastrointestinal Endoscopy recommends a combination of midazolam and meperidine as a standard regimen for inducing sedation in upper and lower gastrointestinal endoscopy.
Several studies reported, however, that midazolam alone or the combination of midazolam and meperidine was insufficient for inducing the sedation effect (47-80%). Besides, midazolam has the disadvantage of producing a paradoxical response at times, which makes the performance of the procedure impossible.
In many studies, propofol, which is preferred as an alternative to midazolam, was recently found to be superior to midazolam in terms of its sedation effect, as it does not cause adverse events.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who are admitted for diagnostic and therapeutic ERCPs
- •aged 20 to 80 years
- •American Society of Anesthesiologists (ASA) classification I to III
排除标准
- •ASA physical status IV and V
- •allergic to any components of sedation and opioid drugs
- •patients with chronic illicit drug use
研究组 & 干预措施
Midazolam-Meperidine-Dexmedetomidine
midazolam 0.06mg/kg IV bolus, meperidine 50mg IV bolus and dexmedetomidine 1μg/Kg•hr infusion (30% reduction of midazolam dose and 25mg of meperidine for patients 65 years of age or older)
干预措施: Dexmedetomidine (Drug)
Midazolam-Meperidine
midazolam 0.06mg/kg IV bolus, meperidine 50mg IV bolus and placebo(saline) infusion(30% reduction of midazolam dose and 25mg of meperidine for patients 65 years of age or older)
干预措施: normal saline (Other)
结局指标
主要结局
Level of sedation
时间窗: During entire procedure(ERCP) time; an expected average of the procedure time is 20 minutes
The sedation level recorded by the RSS and the requirement of the additional sedative (midazolam) or the analgesic (meperidine), and the proportion (%) of cases where adequate sedation was maintained during entire procedure time.
次要结局
- Complication rate(From start point of the procedure(ERCP) to 60 minutes after the procedure)
研究者
Sang Hyub Lee
Assistant Professor of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital
Seoul National University Hospital