Skip to main content
OpenTrials
Completed

NCT Number: NCT02382445

Anesthesia Depth Increases the Degree of Postoperative Dementia, Delirium, and Cognitive Dysfunction

Anesthetics and anesthesia are suspicious to induce dementia or aggravate preexistent cognitive deficits with or without evoking postoperative delirium. In animal trials various anesthetics induce increased levels of misfolded amyloid beta and protein tau, the molecular substance of pathophysiologic brain tissues of demented patients. The amount of those markers seems to correlate well with the degree of dementia [1]. In contradiction, a single study indicates that the incidence of postoperative cognitive deficit (POCD) decreases if hypnotic depth is deep [2]. Unfortunately the study did not sum up the amount of anesthetic drug load, since this would have clarified if the amount of anesthetics used is associated to POCD and dementia. Another possibility is that stress and noxious stimulation induced by light anesthesia results in POCD, whereas deep anesthesia protects from it or inhibits implicit memory.

The investigators' prospective randomized trial is underway to verify the impact of anesthetics and narcotic depth upon grade of dementia and incidence of early postoperative cognitive dysfunction on postoperative day 1 as well as the incidence of delirium within a 90 day period.

The investigators' hypothesis is that the incidence of POCD and delirium and the degree of early cognitive dysfunction is less when anesthetic and vasoactive drug load is less in the BIS- guided anesthesia group with the superficial but sufficient anesthesia level.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diakonissen Hospital

Mannheim, Baden-Wurttemberg, 69163, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adults older than 70 years
  • major surgery ( spine, orthopedic, urologic, gynecology, abdominal)

Exclusion criteria

  • adults younger than 71 years
  • major blood loss surgery
  • allergy to soja oil, nuts, other ingredients of propofol
  • patient wants to have spinal or regional anesthesia only

Treatment and study plan

Anesthesia depth monitor

Device

Other names: Aim at an anesthesia level of BIS 50-60 titrating propofol and sevoflurane in the experimental

sham control

Device

Standard care as usual. Bis m Standard care as usual. Bispectral index monitor is not visible for anesthesia provider.

Propofol and sevoflurane

Drug

Primary outcomes

  1. Postoperative cognition and mental capacity of elderlies following major surgery

    Time frame: One day after surgery

    Mini Mental State Test (MMSE) and automated Memory and Attention Test (MAT) were performed on the day before and after the surgery. The MAT is a validated computerized test for the discrimination of short and long time memory, for visual and auditory comprehension and attention capacity.

Secondary outcomes

  1. Incidence of mental and other complications (serious adverse events)

    Time frame: 90 postoperative days

    Incidences of delirium and mental dysfunction until hospital discharge is counted. Delirium was postoperatively diagnosed by the NUDESC, postoperative cognitive dysfunction (POCD) by the MAT, other serious adverse events in the course of the hospital stay were noted.

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

Anesthesia Depth Increases the Degree of Postoperative Dementia, Delirium, and Cognitive Dysfunction by a Higher Load of Neurotrophic Drugs

Acronym: BIS & Dementia

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 6, 2015
Registry last updated
May 24, 2022

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.

Published trials that share one or more normalized conditions with this study.