Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery

Karolinska University Hospital0 sites8 target enrollmentJune 2013

ConditionsAnesthesia Surgery Neurogenic Inflammation Cognitive Disorders

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Anesthesia
Sponsor: Karolinska University Hospital
Enrollment: 8
Primary Endpoint: Binding of the PET probe [11C]PBR28
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

February 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Karolinska University Hospital

Responsible Party

Principal Investigator

Lars I Eriksson

Professor

Karolinska University Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Patient's refusal to participate in the trial
•Ongoing smoking, snuff or other nicotine compound treatment
•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.
•History of stroke with neurological sequelae
•Surgical procedure scheduled for regional anaesthesia.
•Severe cardia and/or renal and/or hepatic impairment.
•Coagulopathy.
•Terminal phase of a chronic disease.
•Patient on steroidal or non-steroidal anti-inflammatory drugs.
•Admission B-Glucose \> 15 mmol/litre or poorly controlled diabetes mellitus.

Outcomes

Primary Outcomes

Binding of the PET probe [11C]PBR28

Time Frame: Preoperatively, once at postoperative day 2-5 and after 3 month

PET imaging of brain regions of relevance for memory and learning will be compared between the pre- and postoperative states.

Secondary Outcomes

Cognitive testing(Preoperatively and after 3 month)
Inflammatory biomarkers(Preoperatively, once at postoperative day 2-5 and after 3 month, i.e. at the same time as the PET investigation)