Department of Anesthesiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, Amsterdam 1100 DD, The Netherlands.
BMC Gastroenterol. 2013 Dec 30;13:176. doi: 10.1186/1471-230X-13-176.
Endoscopic treatment of early neoplastic lesions in oesophagus has evolved as a valid and less invasive alternative to surgical resection. These endoscopic interventions are minimal invasive treatment options usually done with sedation on an outpatient basis. The aim of this trial is to determine the safety and effectiveness of dexmedetomidine sedation compared to the standard used propofol TCI sedation during endoscopic oesophageal interventions.
The study will be performed as a randomized controlled trial. The first 64 consenting patients will be randomized to either the propofol or the dexmedetomidine group. Following endoscopy patients and gastroenterologists have to fill in questionnaires (PSSI, CSSI) (see abbreviations) about their sedation experiences. Additionally, patients have to accomplish the Trieger test before and after the procedure. Patient monitoring includes time adapted HR, SO₂, ECG, NIBP, exCO₂, NICO, sweat conductance measurement, OAA/S, and the Aldrete score. Effectiveness of sedation, classified by satisfaction levels and pain and sedation score measured by questionnaires is the primary outcome parameter. Respiratory and hemodynamic complications are surrogate parameters for the secondary outcome parameter "safety".
The acceptance level among patients after propofol sedation is high. Dexmedetomidine is a relatively new representative for procedural sedation. Has this new form of conscious sedation the potential to be safer and more effective for patients and endoscopists than propofol during endoscopic oesophageal interventions?
This trial is registered in the ISRCTN Register (ISRCTN 68599804). It will be conducted in accordance with the protocol and in compliance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and Good Clinical Practice (GCP). The Departments of Anesthesiology and Gastroenterology & Hepatology of the Academic Medical Center of Amsterdam are responsible for the design and conduct of the trial.
内镜治疗食管早期肿瘤病变已成为一种有效的、创伤更小的手术切除替代方法。这些内镜干预是微创治疗选择，通常在门诊基础上进行镇静。本试验旨在确定与标准使用丙泊酚 TCI 镇静相比，右美托咪定镇静在内镜食管介入治疗中的安全性和有效性。
该研究将采用随机对照试验进行。前 64 名同意的患者将随机分为丙泊酚组或右美托咪定组。内镜检查后，患者和胃肠病学家必须填写关于镇静体验的调查问卷（PSSI、CSSI）（见缩写）。此外，患者必须在手术前后完成 Trieger 测试。患者监测包括时间适应的 HR、SO₂、ECG、NIBP、exCO₂、NICO、汗液传导测量、OAA/S 和 Aldrete 评分。通过调查问卷测量的满意度水平和疼痛与镇静评分来评估镇静效果，这是主要的观察指标。呼吸和血液动力学并发症是“安全性”次要观察指标的替代参数。
丙泊酚镇静后患者的接受水平较高。右美托咪定是一种相对较新的程序性镇静代表。与丙泊酚相比，这种新形式的清醒镇静是否有可能在食管内镜介入治疗中对患者和内镜医生更安全、更有效？
本试验在 ISRCTN 登记处（ISRCTN 68599804）注册。它将按照方案进行，并符合《赫尔辛基宣言》（1989 年）和《良好临床实践》（GCP）规定的临床研究的道德、伦理和科学原则。阿姆斯特丹学术医学中心的麻醉科和胃肠病学与肝病科负责试验的设计和实施。
