Extrait

Background and study aims Endoscopic treatment of early neoplastic lesions in the oesophagus has become a valid and less invasive alternative than surgical resection. These endoscopic interventions are minimal invasive treatment options usually done with sedation on an outpatient basis. The aim of this study is to determine how well dexmedetomidine sedation works compared to standard propofol/alfentanil sedation during endoscopic oesophageal interventions. Who can participate? Patients planned to undergo an elective endoscopic oesophagus intervention. What does the study involve? Participants are randomly allocated to one of two groups: Group 1 will receive sedation with propofol TCI/alfentanil by an anaesthesia nurse. Group 2 will receive dexmedetomidine by anaesthesia nurse. All patients will receive a validated questionnaire to fill in before and after the procedure. Additionally, endoscopists have to fill in a validated questionnaire. Patients also have to perform the Trieger dot test (combine points with a pen). The following day there is a phone interview with another questionnaire about satisfaction. What are the possible benefits and risks of participating? The study will help answer the question of ‘which form of sedation is most satisfying and safe for patients,’ and to improve sedation management for future patients. There are no additional risks of participating. Where is the study run from? AMC, Amsterdam, the Netherlands When is the study starting and how long is it expected to run for? July 2012 to August 2013 Who is funding the study? AMC, Amsterdam, the Netherlands Who is the main contact? Prof Dr. Dr. M.W. Hollmann [email protected]

Critère d'inclusion

• Elective endoscopic oesophageal interventions

Liens

• isrctn
• ictrp