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Completed

NCT Number: NCT02505815

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

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Erlangen, Dept. Anaesthesiology

Erlangen, Bavaria, 91054, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Surgery

Procedure

Cortisol Level Measurement

Procedure

Neurocognitive Testing

Procedure

Primary outcomes

  1. Neurocognitive Function

    Time frame: 5 Days

    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.

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

Neurocognitive Function After Regional and General Anesthesia: a Randomized Control Trial

Acronym: 245_14_B

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 22, 2015
Registry last updated
Dec 11, 2020

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.

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