Melatonin for Prevention of Postoperative Delirium After Lower Limb Fracture Surgery in Elderly Patients
Status:
Recruiting
Trial end date:
2023-04-30
Target enrollment:
Participant gender:
Summary
Postoperative delirium (POD) is one of the most frequent complications after surgery in
elderly patients, affecting between 20 and 40% of patients older than 60 after major surgery.
This complication has huge consequences for the patients, families and society: increase of
morbidity and mortality, prolonged length of stay, cognitive and functional decline leading
to loss of autonomy, and important additional healthcare costs.
Among numerous risk factors identified, perioperative inflammatory stress is a key element in
delirium genesis: surgical trauma releases danger signals in systemic circulation, activating
immune cells and leading to neuroinflammation.
Melatonin is a neurohormone regulating circadian rhythm. But it also exhibits antioxidant and
free radical scavenger properties, and regulates energy metabolism and immune function. It
has already demonstrated a neuroprotective potential in various animal models. Its use
against delirium is promising: it decreases delirium incidence in elderly patients
hospitalized in medical ward, and several studies are now recruiting in ICU.
The hypothesis of the trial is that in a high-risk population, perioperative melatonin can
reduce the incidence of POD.
The main objective is to evaluate the effect of perioperative melatonin administration on
postoperative delirium incidence in the first 10 days after surgery, in elderly patients
(over 70 years old) being hospitalized and scheduled for acute surgery of fractured lower
limb (from femoral head to tibial plateau).
This is a prospective, national multicentric (21 centers), phase III, superiority,
comparative randomized (1:1) double-blinded clinical trial with two parallel arms:
Experimental group: melatonin 4mg per os every night, starting the evening before surgery (or
2 hours before emergency surgery) and until day 5 after surgery.
Control group: placebo of this drug with the same schedule, during the same period of time.
The patients are aged 70 or older, hospitalized and scheduled for surgery of a severe
fracture of a lower limb (from femoral head to tibial plateau).