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

NCT02505815 | Completed

• 1 other identifier: 2
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neurocognitive Function

Outcome Measures

Primary Outcomes (1)

• Neurocognitive Function

  Using different tests addressing a various quality of neurocognitive function (attention, memory, perceptual and processing speed, alertness and executive function) participants score test appropriate values. Comparing test values separately allows to distinguish between prior - and post - operative status. Moreover it allows to discriminate achieved test results between both groups and calculate statistical differences. Favorable test results lead to a potential better neurocognitive function outcome and enable to assess neurocognitive function in the light of operation consequence.

  5 Days

Study Arms (2)

Regional Anesthesia

Patients with surgery in regional anesthesia.

Procedure: Surgery; Procedure: Cortisol Level Measurement; Procedure: Neurocognitive Testing

General Anesthesia

Patients with surgery in general anesthesia.

Procedure: Surgery; Procedure: Cortisol Level Measurement; Procedure: Neurocognitive Testing

Interventions

Surgery PROCEDURE

General Anesthesia; Regional Anesthesia

Cortisol Level Measurement PROCEDURE

General Anesthesia; Regional Anesthesia

Neurocognitive Testing PROCEDURE

General Anesthesia; Regional Anesthesia

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients recruted at the University Hospital Erlangen prior surgery. Anesthesia procedure eigther in regional or general manner.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University Hospital Erlangen, Dept. Anaesthesiology

Erlangen, Bavaria, 91054, Germany

Location

Related Publications (1)

• 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.

  PMID: 36609226 DERIVED

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: July 22, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 11, 2020

Record last verified: 2020-12

Locations

DE (1)