Extrait

Background and study aims Obstructive sleep apnoea (OSA) is a common condition in which the upper airways (wind pipe) collapse repeatedly during sleep, stopping the flow of air into the lungs. This prevents the sufferer from being able to breathe properly while they are asleep, causing excessive sleepiness throughout their waking hours. Patients with OSA are at risk of developing lung complications following surgery, meaning that use of pain killers and sedatives during care after surgery needs to be restricted. Dexmedetomidine is an anxiety reducing, sedative, and pain medication, which may be useful in the post-operative period for patients with OSA who are having surgery. Ketofol is a medication made from a mixture of ketamine (a medication mainly used for starting and maintaining anesthesia) and propofol (a sedative), which has been shown to be effective at reducing the dose of sedatives needed by patients and so reducing the risk of lung complications. The aim of this study is to look at the effectiveness of dexmedetomine versus ketofol for sedation of patients with OSA after surgery that need help breathing. Who can participate? Adults aged between 18 and 50 years who have obstructive sleep apnea and require mechanical ventilation. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group receive dexmedetomine through a drip and those in the second group receive ketofol through a drip to provide sedation. Both groups receive sedation for a total of 12 hours after surgery while they undergo mechanical ventilation (use of a breathing machine). The length of time they need to stay on the breathing machine and the length of their hospital stay is recorded. In addition, their vital signs are monitored throughout. What are the possible benefits and risks of participating? There are no notable benefits or risks involved with participating. Where is the study run from? Benisuef University Hospital (Egypt) When is the study starting and how long is it expected to run for? May 2016 to April 2017 Who is funding the study? Investigator initiated and funded (Egypt) Who is the main contact? Dr Hatem Elmoutaz [email protected]

Critère d'inclusion

• Obstructive Sleep Apnea

Liens

• isrctn