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

NCT ID: NCT02382445

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-05-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Anesthesia depth monitor

Anesthesia depth is aimed to be between BIS 50-60

Group Type: EXPERIMENTAL

Anesthesia depth monitor

Intervention Type: DEVICE

propofol and sevoflurane

Intervention Type: DRUG

Control group

Anesthesia depth is monitored but blinded to the anesthesiologist

Group Type: SHAM_COMPARATOR

Sham control

Intervention Type: DEVICE

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

propofol and sevoflurane

Intervention Type: DRUG

Interventions

Anesthesia depth monitor

Intervention Type: DEVICE

Sham control

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

Intervention Type: DEVICE

propofol and sevoflurane

Intervention Type: DRUG

Other Intervention Names

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

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Thomas Frietsch

Prof. Dr. med. Thomas Frietsch

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Frietsch, Prof, MD

Role: STUDY_DIRECTOR

Universitätsmedizin Mannheim

Locations

Diakonissen Hospital

Mannheim, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

BIS-Diako-Ma-2014

Identifier Type: -

Identifier Source: org_study_id