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Completed

NCT Number: NCT02698982

Optimized Anesthesia to Reduce Postoperative Cognitive Impairment in the Elderly

The aim of this study is to demonstrate that in elderly and frail patients, a narrower control of intraoperative blood pressure (BP) by the use of a continuous and noninvasive BP monitoring, coupled with an adequate depth of anesthesia, will reduce the incidence of postoperative cognitive impairment and the hospital length of stay.

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Key information

Conditions

Elderly ; Moderate Risk Surgery Cognition Disorders Cognitive Dysfunction Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasme Hospital

Brussels, 1070, Belgium

About this study

Postoperative cognitive impairment (delirium and cognitive dysfunction) are frequent and feared complications in the elderly; they increase the postoperative morbidity and mortality, worsen the cognitive and functional outcome with loss of independence and increase the hospitalization length and costs . However, the etiology of these postoperative cognitive impairment, although probably multifactorial, remains unclear and strongly debated.

The investigators hypothesize that excessive anesthesia depths associated with intraoperative hypotension may play a critical role in the pathogenesis of cognitive impairment following surgery.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elderly patients (over the age of 70) undergoing elective moderate risk surgery requiring a general anesthesia
  • Patients who provide written informed consent
  • patient fluent in french

Exclusion criteria

  • Patients under 70 years of age
  • Surgery under locoregional anesthesia or emergent surgery or minor risk surgery
  • Patients requiring invasive blood pressure monitoring (for medical reason or high risk surgery)
  • Patients with arrhythmia and/or atrial fibrillation
  • Patients with preoperative delirium or cognitive dysfunction (moca test < 26)
  • Patients not fluent in French
  • Patients without the capacity to give written informed consent or refusal of consent
  • Patients undergoing surgery or included in another protocol within 3 months

Treatment and study plan

Depth of anesthesia monitoring (BIS, Covidien USA) and Continus non invasive blood pressure monitoring (Clearsight, Edwards LifeScience, USA)

Device

moderate risk surgery

Procedure

Primary outcomes

  1. postoperative delirium detected by the Confusion Assessment Method (CAM)

    Time frame: 3 day postoperative

    Screening of postoperative delirium by the CAM, every day until the 3rd postoperative day

Secondary outcomes

  1. postoperative change in cognitive function detected by a battery of neuropsychological test.

    Time frame: baseline and 1 week and 3 month postoperative

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

Impact of Tight Intraoperative Blood Pressure and Depth of Anesthesia Control on the Incidence of Postoperative Cognitive Impairment in Elderly Patients

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 4, 2016
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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