The Impact of the Implementation of BIS on the Incidence of Postoperative Delirium

NCT04736303 | Unknown

• 1 other identifier: POD and BIS
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the incidence of postoperative POD in patients undergoing non cardiac surgery under general anesthesia with and without the implementation of the BIS monitoring.T

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• Incidence of POD

  Assess the incidence of POD with CAM and Nu-DESC tools

  1st postoperative day

Study Arms (2)

POD without BIS

NO INTERVENTION

Assessing the incidence of POD in patients under general anethesia for elective non cardiac surgery, with CAM and Nu-DESC tools.

POD with BIS

ACTIVE COMPARATOR

Assessing the incidence of POD in patients under general anethesia for elective non cardiac surgery with the implementation of BIS monitoring, with CAM and Nu-DESC tools.

Device: BIS

Interventions

BIS DEVICE

The implementation of BIS monitoring

POD with BIS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients over 60 years of age
• an American Society of Anesthesiologists (ASA) physical status I to III
• undergoing elective non cardiac surgery under general anaesthesia
• native speakers of the Greek language
• eligible to leave the post-anaesthesia care unit
• an expected in-hospital stay at least 24 hours following surgery

You may not qualify if:

• refused to participate or sign the informed consent form
• surgery or anaesthesia within the last 30 day
• any prior or current history involving an affliction of the central nervous system
• severe hearing or visual impairment
• psychiatric disorders
• a score less than 5 according the Geriatric Depression Scale (GDS-15)
• a score less than 4 for females and less than 2 for males according to the Lawton-Brody Instrumental Activities of Daily Living Scale (I.A.D.L.)
• alcohol consumption less than 35 units/week
• drug dependence
• previous neuropsychological testing
• haemodynamical instability
• peri-procedural desaturation (one or more events of SpO2\<80% for more than 2 minutes)

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

Univeristy of Thessaly

Larissa, Thessaly, 41110, Greece

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Eleni Arnaoutoglou, MD, PhD

  University of Thessaly

  STUDY CHAIR

• Maria Ntalouka, MD, PhD

  University Hospital of Larissa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleni Arnaoutoglou, MD, PhD

CONTACT

+306974301352; earnaout@gmail.com

Maria Ntalouka, MD, PhD

CONTACT

+306973688099; maria.ntalouka@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: February 3, 2021
• Study Start: December 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: April 1, 2023
• Last Updated: August 19, 2022

Record last verified: 2022-08

Locations

GR (1)