Remifentanil Versus Fentanyl in Mechanically Ventilated Critically Ill Patients: Study Protocol for a Randomized Controlled Study
Remifentanil Versus Fentanyl in Mechanically Ventilated Critically Ill Patients: Study Protocol for a Randomized Controlled Study
Yin-Hua Wang1,2, Yi-Bing Zhu1, Li Jiang1, Bin Du3 and Xiu-Ming Xi1*
ABSTRACT
Opioids are commonly required to relieve pain in critically ill patients, especially for those under mechanical ventilation (MV). Remifentanil, a potent μ-opioid receptor with a rapid onset and offset, is widely used in anesthesia during surgeries, whereas less commonly administrated in the intensive care unit (ICU). This study is designed as a prospective, randomized, double-blind, controlled, parallel-group trial. Eligible 254 adult patients in ICU requiring MV for more than 24 h and ventilated for less than 48 h at the enrollment are randomly assigned to either the ‘remifentanil group’ or the ‘fentanyl group’, in which opioids will be infused for a maximum of 14 days. The primary outcome is the duration of MV. Secondary outcomes include the duration of extubation, costs and length of stay (LOS) in ICU, dose adjustment time, analgesic and sedative agent costs, short-term mortality, and adverse events potentially relevant to the study drugs. Data analysis will adopt an intention-to-treat approach. This trial will demonstrate the probability that remifentanil can reduce the duration of MV in long-term ventilated patients in critically ill patients compared to fentanyl.
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