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

NCT02382445 | Completed

• 1 other identifier: BIS-Diako-Ma-2014
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Delirium; Dementia; Bispectral Index Monitor

Outcome Measures

Primary Outcomes (1)

• Postoperative cognition and mental capacity of elderlies following major 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.

  One day after surgery

Secondary Outcomes (1)

• Incidence of mental and other complications (serious adverse events)

  90 postoperative days

Study Arms (2)

Anesthesia depth monitor

EXPERIMENTAL

Anesthesia depth is aimed to be between BIS 50-60

Device: Anesthesia depth monitor; Drug: propofol and sevoflurane

Control group

SHAM COMPARATOR

Anesthesia depth is monitored but blinded to the anesthesiologist

Device: Sham control; Drug: propofol and sevoflurane

Interventions

Anesthesia depth monitor DEVICE

Also known as: Aim at an anesthesia level of BIS 50-60 titrating propofol and sevoflurane in the experimental

Anesthesia depth monitor

Sham control DEVICE

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

Control group

propofol and sevoflurane DRUG

Anesthesia depth monitor; Control group

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Diakonissen Hospital

Mannheim, Baden-Wurttemberg, 69163, Germany

Location

MeSH Terms

Conditions

Delirium; Dementia

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Thomas Frietsch, Prof, MD

  Universitätsmedizin Mannheim

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Thomas Frietsch

Study Record Dates

• First Submitted: August 11, 2014
• First Posted: March 6, 2015
• Study Start: January 1, 2014
• Primary Completion: May 8, 2017
• Study Completion: May 8, 2017
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

DE (1)