Target Hemodynamics and Brain Injury During General Anesthesia in the Elderly
Status:
Suspended
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
BACKGROUND: Post-operative cognitive dysfunction (POCD) is a potentially irreversible loss of
brain functions observed in elderly patients after surgical operations under general
anaesthesia. POCD at 3 post-operative months is observed in up to 15% of patients aged 70
years and more, and the only recognized risk factor for this condition is increasing age.
Importantly, the incidence of POCD at 3 months has been associated to an increased disability
and mortality.
OBJECTIVES: The present study will evaluate in patients aged 75 years and older undergoing
general anaesthesia for non-cardiac surgery, whether an hemodynamic strategy, aiming at
maintaining intra-operative arterial blood pressure close to patient's preoperative blood
pressure, i.e., to avoid hypotensive episodes, reduces the incidence of POCD at three months.
METHODS: Around 1800 consecutive patients scheduled to undergo general anaesthesia for
elective non-cardiac surgery will be enrolled. Each patient's cognitive function will be
evaluated preoperatively and at 3 months and 1 year postoperatively, together with the
occurrence of hearing loss and vestibular function impairment. Furthermore, the incidence of
postoperative delirium and cardiovascular, respiratory and infectious complications will be
evaluated.
EXPECTED RESULTS: The primary outcome is a 25% relative reduction in the incidence of POCD at
3 postoperative months. Secondary outcomes are the reduction of POCD incidence at 1
postoperative year, a reduction in postoperative hearing loss and vestibular impairment at 3
months, a reduction in the incidence of delirium. Hospital length of stay and 90 day
mortality will also be assessed. This present study could have a high socio-economic impact,
reduce healthcare costs and patient morbidity and mortality with a simple not expensive
intraoperative intervention.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico