MedDataX Logo

Neurocognitive Function After Regional and General Anesthesia (245_14 B)

NCT ID: NCT02505815

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Postoperative cognitive dysfunction (POCD) is a disease with restricted cognitive memory function and intellectual skills, which occurs after surgery with and without anesthesia. The POCD strongly depends on patient's age and the surgical operation type. The anesthesia procedure plays a pivotal role as well and regarding the current knowledge it is still uncertain which technique matches the lowest risk. Elevated stress level accompanied with regional anesthesia procedures are accused to cause POCD in elderly patients. The investigators address the question weather regional or general anesthesia leads to a pronounced POCD in dependence of stress incidence.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Postoperative cognitive dysfunction (POCD) is a disease with restricted cognitive memory function and intellectual skills, which occurs after surgery with and without anesthesia. The limiting cognitive ability leads to a lack of quality of life for a lot of patients. The POCD strongly depends on patient's age and the surgical operation type. In aged adults the incidence of POCD after one week following surgery is 25,8%. Risk factors for the development of a POCD is beside age less education and a reduced cognitive reserve. However, the anesthesia procedure plays a pivotal role as well and regarding the current knowledge it is still uncertain which technique matches the lowest risk. Elevated stress level accompanied with regional anesthesia procedures are accused to cause POCD in elderly patients. This fact leads to the question if a general anesthesia technique has a lower stress level and consequently leads to a reduced risk for a POCD development. Likewise the investigators address this hypothesis and analyze cognitive function following both anesthesia techniques separately in elderly patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neurocognitive Function

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Regional Anesthesia

Patients with surgery in regional anesthesia.

Surgery

Intervention Type PROCEDURE

Cortisol Level Measurement

Intervention Type PROCEDURE

Neurocognitive Testing

Intervention Type PROCEDURE

General Anesthesia

Patients with surgery in general anesthesia.

Surgery

Intervention Type PROCEDURE

Cortisol Level Measurement

Intervention Type PROCEDURE

Neurocognitive Testing

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Surgery

Intervention Type PROCEDURE

Cortisol Level Measurement

Intervention Type PROCEDURE

Neurocognitive Testing

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients within 50-85 years of age both gender.

Exclusion Criteria

* Patients under 50 years of age or older than 85 years of age.
* Preexisting neurological, neuropsychological deficits or diseases, e.g. cerebral insult or epilepsy.
* Preexisting neurological, neuropsychological medication, preexisting neuromuscular diseases.
* Alcohol- and drug abuse. Postoperative complications, pain and time shifts within the test protocol.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Erlangen, Dept. Anaesthesiology

Erlangen, Bavaria, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Wagner S, Breitkopf M, Ahrens E, Ma H, Kuester O, Thomas C, von Arnim CAF, Walther A. Cognitive function in older patients and their stress challenge using different anesthesia regimes: a single center observational study. BMC Anesthesiol. 2023 Jan 6;23(1):6. doi: 10.1186/s12871-022-01960-7.

Reference Type DERIVED
PMID: 36609226 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2

Identifier Type: -

Identifier Source: org_study_id