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

Neurocognitive Function Clinical Trial

— 245_14_B  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02505815
• Other study ID #: 2
• Status: Completed
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: December 2020
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neurocognitive Function

Intervention

Procedure:
• Surgery

• Cortisol Level Measurement

• Neurocognitive Testing

Locations

Country	Name	City	State
Germany	University Hospital Erlangen, Dept. Anaesthesiology	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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