drugset / Trial / NCT02428062

Target Hemodynamics and Brain Injury During General Anesthesia in the Elderly

NCT02428062

RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2014-10
Primary completion
2018-12
Completion
2019-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Background Dopamine Small molecule 5 ug/kg Intravenous
Background Dopamine Small molecule 10 ug/kg Intravenous
Background Ephedrine Small molecule 5 mg Intravenous
Background Ephedrine Small molecule 25 mg Intravenous
Background Epinephrine Other / unclassified 5 ug Intravenous
Background Epinephrine Other / unclassified 10 ug Intravenous
Background Norepinephrine Other / unclassified 0.01 ug/kg Intravenous
Background Norepinephrine Other / unclassified 0.1 ug/kg Intravenous
Background Phenylephrine Small molecule 0.1 mg Intravenous
Background Phenylephrine Small molecule 0.2 mg Intravenous

Indications

No indication recorded.