Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery

NCT ID: NCT01881646

Last Updated: 2017-01-11

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-02-29

Brief Summary

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The main purpose of this study is to assess the induction of neuroinflammation in brain regions of interest for learning and memory in adult patients undergoing urological surgery under general anesthesia

Detailed Description

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The investigators aim to study immune cell activation as a biomarker for neuroinflammation using the cell specific \[11C\]PBR28 probe as detected by PET imaging techniques.

Conditions

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Anesthesia Surgery Neurogenic Inflammation Cognitive Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Positron emission tomography (PET)

Positron emission tomography (PET) using \[11C\]PBR28

Group Type EXPERIMENTAL

Positron emission tomography (PET) using [11C]PBR28

Intervention Type RADIATION

Interventions

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Positron emission tomography (PET) using [11C]PBR28

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

1. Patients 60-75 years of age. American Society for Anesthesiologist' criteria (ASA) physical status I-III
2. Lower abdominal surgery (hysterectomy/prostatectomy) under general anaesthesia
3. Obtained consent within 3 months before execution of the study.

Exclusion Criteria

1. Patient's refusal to participate in the trial
2. Ongoing smoking, snuff or other nicotine compound treatment
3. Disabling neuropsychiatrical disorder (a Mini mental State Examination (MMSE) score ≤ 24, diagnosis of dementia, Mb Alzheimer, Mb Parkinson, schizophrenia, or mental depression) or other signs of significant cognitive decline.
4. History of stroke with neurological sequelae
5. Surgical procedure scheduled for regional anaesthesia.
6. Severe cardia and/or renal and/or hepatic impairment.
7. Coagulopathy.
8. Terminal phase of a chronic disease.
9. Patient on steroidal or non-steroidal anti-inflammatory drugs.
10. Admission B-Glucose \> 15 mmol/litre or poorly controlled diabetes mellitus.
11. Presumed uncooperativeness or legal incapacity.
12. Preoperative or later postoperative B-hemoglobin \< 90 g/L.
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lars I Eriksson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars I Eriksson, MD,PhD, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital and Karolinska Institutet

Other Identifiers

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POPE

Identifier Type: -

Identifier Source: org_study_id

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