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

Completed

• Conditions: Neurocognitive Function
• Interventions: Procedure: Surgery; Procedure: Cortisol Level Measurement; Procedure: Neurocognitive Testing

• Registration Number: NCT02505815
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed 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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-06-11
• Study First Submitted QC: 2015-07-20
• Study First Posted: 2015-07-22
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Regional Anesthesia	Surgery	Patients with surgery in regional anesthesia.
Regional Anesthesia	Cortisol Level Measurement	Patients with surgery in regional anesthesia.
General Anesthesia	Surgery	Patients with surgery in general anesthesia.
Regional Anesthesia	Neurocognitive Testing	Patients with surgery in regional anesthesia.
General Anesthesia	Cortisol Level Measurement	Patients with surgery in general anesthesia.
General Anesthesia	Neurocognitive Testing	Patients with surgery in general anesthesia.

Primary Outcome Measures

Name	Time	Method
Neurocognitive Function	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.

Trial Locations

Locations (1)

University Hospital Erlangen, Dept. Anaesthesiology; 🇩🇪 Erlangen, Bavaria, Germany