Optimized Anesthesia to Reduce Postoperative Cognitive Impairment in the Elderly

Elderly ; Moderate Risk Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02698982
• Other study ID #: P2015/539
• Status: Completed
• Phase: N/A
• First received: February 12, 2016
• Last updated: December 22, 2017
• Start date: May 2016
• Est. completion date: March 2017

Study information

• Verified date: December 2017
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Elderly ; Moderate Risk Surgery

Intervention

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

Procedure:
• moderate risk surgery

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative delirium detected by the Confusion Assessment Method (CAM)	Screening of postoperative delirium by the CAM, every day until the 3rd postoperative day	3 day postoperative
Secondary	postoperative change in cognitive function detected by a battery of neuropsychological test.		baseline and 1 week and 3 month postoperative