Journal of Clinical Trials
Open Access
ISSN: 2167-0870
ISSN: 2167-0870
Ting Li
ScientificTracks Abstracts-Workshop: J Clin Trials
Background: Patients with hip fractures have the high incidence of delirium. Postoperative delirium (POD) leads to length
of hospital stay, nursing requirements, increases healthcare cost, higher mortality and poor functional recovery. The majority
of general anesthetic and sedative agents may favor POD. However, none of studies have investigated the effect of regional
anesthesia and general anesthesia on the POD in elderly patients undergoing hip fracture surgery in China. Our research
hypotheses are: Regional anesthesia may contribute to decrease the incidence of POD. Regional anesthesia may improve the
outcome of elderly patient and reduce healthcare costs associated with POD. POD may result in poor long-term functional
outcomes.
Methods & Design: This phase 3 study is a multicenter, randomized, open-label and controlled trial. The primary objective
of this study is to evaluate the incidence of POD for a period of 7 days after regional/general anesthesia in elderly patients
undergoing hip fracture surgery diagnosed with the Confusion Assessment Method (CAM). The secondary objectives of
this study are: To evaluate the type, severity and duration of delirium to evaluate the healthcare costs associated with POD;
to evaluate the recovery parameters; to evaluate the long-term functional outcomes of elderly patient with POD. The target
population are older patient (≥65 years) with hip fracture and planned hip fracture surgery; patient willing to complete this
study. A total of 1000 patients will be randomized into 2 study groups (received regional anesthesia or general anesthesia) in
the 9 participating centers clinical trial.
Conclusion: In conclusion, the results of this comparative anesthesiological trial should allow us to detect whether anesthesia
is related to POD rate. This information could ultimately help in selecting the most appropriate anesthesia in patients with high
risk for POD.
Trial status: Patients are being recruited in three centers currently. The study was initiated in September 2014. To date, 50
patients have been randomized (January 2015) in this study. Recruitment of patients is about 50% slower than expected. So the
recruitment period of this trial will be extended from the September of 2015 to the September of 2016. Approximately three
out of ten screened patients have been enrolled.