title: Safety and effectiveness using dexmedetomidine versus propofol TCI sedation during oesophagus interventions: a randomized trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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".
  
  
  CONCLUSIONS
  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?
  
  
  BACKGROUND
  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.
authors.affiliation: Department of Anesthesiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, Amsterdam 1100 DD, The Netherlands. S.Eberl@amc.uva.nl.
authors.forename: Susanne
authors.initials: S
authors.lastname: Eberl
authors.forename: Benedikt
authors.initials: B
authors.lastname: Preckel
authors.forename: Jacques J
authors.initials: JJ
authors.lastname: Bergman
authors.forename: Markus W
authors.initials: MW
authors.lastname: Hollmann
mesh_terms: D001471:Barrett Esophagus / Q000601:surgery*; D017115:Catheter Ablation / Q000379:methods; D016292:Procedural Sedation / Q000379:methods*; D020927:Dexmedetomidine / Q000627:therapeutic use*; D004945:Esophagoscopy / Q000379:methods*; D004947:Esophagus / Q000601:surgery*; D006801:Humans; D006993:Hypnotics and Sedatives / Q000627:therapeutic use*; D009092:Mucous Membrane / Q000601:surgery*; D010149:Postoperative Pain; D017060:Patient Satisfaction; D015742:Propofol / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D006993:Hypnotics and Sedatives; D020927:Dexmedetomidine; D015742:Propofol