Are there risks involved in the HYPOTHERMIA study?
The potential risks involved in this trial include the following: discomfort or pain, too large of a temperature drop and fluid overload. There are safety measures built into the protocol to minimize any of these risks. In the studies cited above there have not been any of these complications reported. All subjects enrolled in this trial are unconscious and therefore should not experience any pain. All subjects have an esophageal thermometer placed in order to accurately measure body temperature. These thermometers are routinely placed, with minimal discomfort, in hospitalized patients. A medicine, called pancuronium, is given to prevent shivering or moving. Paramedics breathe for subjects during this time. Pancuronium works by paralyzing all the muscles of the body, but does not cause sedation or relaxation. A second medicine called diazepam is administered to keep subjects sedated so that, in the event that awakening occurs, subjects are not aware. There is a small risk of prolonged
