Target Hemodynamics and Brain Injury During General Anesthesia in the Elderly

NCT02428062 | Suspended Phase 2

• 1 other identifier: TB-POCD
• Study Type: interventional
• Target: 1,812
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-operative Cognitive Dysfunction

Keywords

Post-operative complications; Mild cognitive impairment; Delirium

Outcome Measures

Primary Outcomes (1)

• Post-operative cognitive dysfunction (POCD) at 3 months

  For each of the neuropsychological tests a Z-score will be calculated. The Z score represents the magnitude of the deviation (in number of standard deviations) in the test results from the reference (Control Group). The Z-score is calculated as the difference between the baseline and the 3 months test result for a patient, corrected for the expected difference (the mean difference for that test observed in the Control Group), divided by the standard deviation of the mean difference for that test observed in the Control Group. From the Z-scores of the single tests a combined Z-score can be calculated. Patients in whom the difference (worsening) in the score at 3 months to the score at baseline in at least 2 tests will be greater than 2 standard deviations from the expected difference (i.e. Z-score ≥ 2 in at least 2 tests), will be diagnosed with POCD. Also patients in which the combined Z-score will be equal or greater than 2 will be diagnosed with POCD.

  3 months after surgical operation

Secondary Outcomes (9)

• Post-operative cognitive dysfunction (POCD) at 1 year

  1 year after surgical operation

• Post-operative delirium

  Within 7 days after surgical operation

• Hearing loss at 3 months

  3 months after surgical operation

• Hospital length of stay

  Up to 30 days after surgical operation

• Mortality

  90 days

Other Outcomes (4)

• Per protocol analysis of outcomes

  Up to 30 days after surgical operation, at 3 months and 1 year

• Intraoperative hypotensive times

  Up to 30 days after surgical operation, at 3 months and 1 year

• Intraoperative cerebral desaturations

  Up to 30 days after surgical operation, at 3 months and 1 year

Study Arms (3)

Standard-of-Care

NO INTERVENTION

The intraoperative hemodynamic management of the patients assigned to this arm will be left to the discretion of the anesthesiologist, without any indication as to the intraoperative hemodynamic strategy to be adopted.

Treatment

EXPERIMENTAL

The anesthesiologist will have as hemodynamic target for patients assigned to this arm the maintenance of mean arterial blood pressure within 10% of the baseline blood pressure value (recorded at the preoperative evaluation). The strategy to reach this hemodynamic target will be left to the clinical judgment of the anaesthesiologist in charge. The possible strategies include a vasoconstrictor agent (either phenylephrine, ephedrine, epinephrine, norepinephrine or dopamine), intravenous fluids, patient's positioning or reduction of depth of anesthesia.

Procedure: Hemodynamic target; Drug: Phenylephrine; Drug: Intravenous fluids; Procedure: Patient's positioning; Procedure: Reduction of depth of anesthesia; Drug: Ephedrine; Drug: Epinephrine; Drug: Norepinephrine; Drug: Dopamine

Control

NO INTERVENTION

Subjects assigned to this arm will undergo the same geriatric, neuropsychologic and audiologic evaluations administered to patients of the "Standard-of-Care" and "Treatment" arms at the same time points (baseline, 3 months and 1 year). These subjects will not undergo any surgical procedure and will therefore not be evaluated for post-operative complications or delirium occurrence.

Interventions

Hemodynamic target PROCEDURE

The anaesthesiologist is requested to maintain intraoperative mean arterial blood pressure of the patient within 10% of the baseline mean arterial blood pressure (recorded during the preoperative evaluation) of that patient. In order to reach this hemodynamic target the anesthesiologist can choose between one or more of the following four sub-interventions: 1. vasoconstrictor agents (either phenylephrine, ephedrine, epinephrine, norepinephrine or dopamine) 2. intravenous fluids 3. patient's positioning 4. reduction of depth of anesthesia

Treatment

Phenylephrine DRUG

Phenylephrine 0.1-0.2 mg intravenous bolus

Also known as: Sub-intervention 1: Vasoconstrictor agent

Treatment

Intravenous fluids DRUG

A crystalloid fluid bolus is given intravenously (5-10 ml/kg)

Also known as: Sub-intervention 2

Treatment

Patient's positioning PROCEDURE

The operating table is positioned so that the patient's head lies below the level of the patient's feet (Trendelenburg position) in order to increase venous return

Also known as: Sub-intervention 3

Treatment

Reduction of depth of anesthesia PROCEDURE

The halogenated anesthetic vapor's inspiratory fraction is decreased in order to reduce the associated peripheral vasodilation

Also known as: Sub-intervention 4

Treatment

Ephedrine DRUG

Ephedrine 5-25 mg intravenous bolus

Also known as: Sub-intervention 1: Vasoconstrictor agent

Treatment

Epinephrine DRUG

Epinephrine 5-10 mcg intravenous bolus

Also known as: Sub-intervention 1: Vasoconstrictor agent

Treatment

Norepinephrine DRUG

Norepinephrine 0.01 - 0.1 mcg/kg/min intravenous continuous infusion

Also known as: Sub-intervention 1: Vasoconstrictor agent

Treatment

Dopamine DRUG

Dopamine 5 - 10 mcg/kg/min intravenous continuous infusion

Also known as: Sub-intervention 1: Vasoconstrictor agent

Treatment

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; Via F. Sforza 35

Milan, 20135, Italy

Location

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MeSH Terms

Conditions

Cognitive Dysfunction; Delirium

Interventions

Phenylephrine; Ephedrine; Epinephrine; Norepinephrine; Dopamine

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Propanolamines; Propanols; Phenethylamines; Ethylamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Luciano Gattinoni, MD, FRCP

  Dipartimento di anestesiologia terapia intensiva e scienze dermatologiche

  PRINCIPAL INVESTIGATOR

• Thomas Langer, MD

  Dipartimento di Anestesia, Rianimazione ed Emergenza Urgenza, Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico, Milano, Italy

  STUDY CHAIR

• Alessandro Santini, MD

  Dipartimento di anestesiologia terapia intensiva e scienze dermatologiche

  STUDY CHAIR

• Michael Quintel, MD, PhD

  University of Göttingen, Zentrum Anaesthesiologie-, Rettungs- und Intensivmedizin

  STUDY CHAIR

• Antonio Pesenti, MD

  Dipartimento di Emergenza Urgenza, Azienda Ospedaliera San Gerardo, Monza,Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 28, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: April 13, 2018

Record last verified: 2018-04

Locations

IT (1)