Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation - Effects on Physical Function

The experimental group will not receive sedatives. Patients are thoroughly and repeatedly informed by the staff of where they are, what have happened, and what type of treatment they are going to receive.

Participants will be awake and have a natural sleep rhythm. In case these patients develop and outward delirium, it is necessary to have a nurse or other caregiver at the bedside in order to calm the patient. Patients with delirium will be treated with haloperidol.

The control group will be sedated to Ramsay score 3-4. The first 48 hours the patients will be sedated with propofol, after 48 hours midazolam will be used. During daytime, the patient will be awakened as the intravenous infusion of sedatives will be discontinued. The patient will be considered to be awake when he/she can perform at least three of the following four tasks:

• Open the eyes to verbal commands.
• Follow the examiner's instructions with the eyes.
• Squeeze hands on request.
• Stick out the tongue on request.

After a successful wake-up, the infusion of sedative will be resumed, starting on half of the pre-wake-up dose and adjusted to Ramsey score 3-4.

• Standard treatment, continuous iv-sedation

Co-primary outcome of: patient-reported quality of life, as measured by SF-36v2, physical component and degree of independence in activities of daily living, as measured by Barthel Index.

Since this is a co-primary outcome, the type I error probability associated with the test of the null hypothesis should be less than 0,025.