Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery (POPE)

January 10, 2017 updated by: Lars I Eriksson, Karolinska University Hospital
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

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Positron emission tomography (PET)
Positron emission tomography (PET) using [11C]PBR28

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Preoperatively, once at postoperative day 2-5 and after 3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive testing
Time Frame: Preoperatively and after 3 month
Postoperative cognitive test battery according to the ISPOCD protocol, see Moller JT et al, Lancet 1998.
Preoperatively and after 3 month
Inflammatory biomarkers
Time Frame: Preoperatively, once at postoperative day 2-5 and after 3 month, i.e. at the same time as the PET investigation
Inflammatory biomarkers and genetic analysis of inflammatory biomarkers in blood.
Preoperatively, once at postoperative day 2-5 and after 3 month, i.e. at the same time as the PET investigation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Lars I Eriksson, MD,PhD, Professor, Karolinska University Hospital and Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

June 13, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (ESTIMATE)

June 19, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgery

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

3
Subscribe