Target Hemodynamics and Brain Injury During General Anesthesia in the Elderly

• Status: Suspended
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Treatments: Anesthetics; Dopamine; Dopamine Agents; Ephedrine; Epinephrine; Epinephryl borate; Norepinephrine; Oxymetazoline; Phenylephrine; Pseudoephedrine; Racepinephrine; Vasoconstrictor Agents

Criteria

Inclusion Criteria:

• any patient aged 75 years and more scheduled for elective non-cardiac surgery under general anesthesia.

Exclusion criteria:

• Failure to obtain informed consent to the study;

• Impossibility to perform scheduled geriatric and neuropsychological tests during the preoperative evaluation;

• Mini-mental state examination score (corrected for age and education) ≤ 23 at the preoperative evaluation;

• Patients scheduled to undergo intracranic neurosurgical procedures or vascular surgery;

• Patients who have been subjected to a surgical procedure under general anesthesia in the preceding 6 months;

• Patients with metastatic cancer; patients falling in the category of the American Society of Anaesthesiologists (ASA) physical status 4;

• Patients already included in the study, i.e. second surgical procedure;

Inclusion criteria for the Control Group:

• Subjects of 75 years and more in whom no hospitalization or surgical procedure is scheduled in the following 3 months.

Exclusion criteria for the Control Group:

• Failure to obtain informed consent to the study;

• Impossibility to perform scheduled geriatric and neuropsychological tests during the baseline evaluation;

• Mini-mental state examination score (corrected for age and scholarity) ≤ 23 at the baseline evaluation;

• Subjects who have undergone a surgical procedure under general anesthesia in the preceding 6 months;

• Subjects who have undergone an unexpected surgical procedure under general anesthesia in the timeframe between baseline 3 months evaluation.