Femme et Homme
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Extrait
Background and study aims The number of colonoscopies as screening procedures has increased in recent years and will continue to so in the near future. Patients undergoing such procedures expect safe and comfortable environments. It is not surprising that the number of patients and endoscopists' requests for sedation has also increased. The aim of our study is to investigate the differences in patient and endoscopist's level of satisfaction and experience and how safe the different sedation methods are. Who can participate? Patients undergoing elective diagnostic or therapeutic colonoscopy, over 18 years old. What does the study involve? Patients will randomly allocated to three groups for three commonly used sedations. Group 1 will receive sedation with midazolam/fentanyl by gastroenterologist, Group 2 will receive sedation with propofol TCI/ alfentanil by anaesthesia nurse, and Group 3 will receive alfentanil by gastroenterologist. All patients will fill in a questionnaire before and after the procedure. Endoscopists will also have to fill in a questionnaire. Patients will also have to perform the Trieger dot test (combine points with a pen). Patients in all three groups will be monitored in the standard way and will receive a face mask with 2l of oxygen from start of sedation till the end of the endoscopic procedure. Interventions will be monitored using a video assisted camera system. In the recovery room patients will be monitored and will stay for 1 hour. The following day there will a phone interview with another questionnaire about satisfaction. What are the possible benefits and risks of participating? The benefits include: answers to as to which form of sedation is most satisfying and safe for patients and improved sedation management for future patients. There are no additional risks of participating. Where is the study run from? Academic Medical Centre (AMC), Amsterdam, the Netherlands When is the study starting and how long is it expected to run for? The study ran from October 2010 to March 2011. Who is funding the study? Internal funding AMC Who is the main contact? Prof Dr. Dr. M.W. Hollmann [email protected]
Critère d'inclusion
- Elective colonoscopies for diagnostic or therapeutical interventions