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Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery (POPE)

Primary Purpose

Anesthesia, Surgery, Neurogenic Inflammation

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Positron emission tomography (PET) using [11C]PBR28
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Anesthesia focused on measuring Neuroinflammation, Postoperative cognitive dysfunction

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Positron emission tomography (PET)

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Binding of the PET probe [11C]PBR28
    PET imaging of brain regions of relevance for memory and learning will be compared between the pre- and postoperative states.

    Secondary Outcome Measures

    Cognitive testing
    Postoperative cognitive test battery according to the ISPOCD protocol, see Moller JT et al, Lancet 1998.
    Inflammatory biomarkers
    Inflammatory biomarkers and genetic analysis of inflammatory biomarkers in blood.

    Full Information

    First Posted
    June 13, 2013
    Last Updated
    January 10, 2017
    Sponsor
    Karolinska University Hospital
    Collaborators
    University of Copenhagen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01881646
    Brief Title
    Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery
    Acronym
    POPE
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karolinska University Hospital
    Collaborators
    University of Copenhagen

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anesthesia, Surgery, Neurogenic Inflammation, Cognitive Disorders
    Keywords
    Neuroinflammation, Postoperative cognitive dysfunction

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Positron emission tomography (PET)
    Arm Type
    Experimental
    Arm Description
    Positron emission tomography (PET) using [11C]PBR28
    Intervention Type
    Radiation
    Intervention Name(s)
    Positron emission tomography (PET) using [11C]PBR28
    Primary Outcome Measure Information:
    Title
    Binding of the PET probe [11C]PBR28
    Description
    PET imaging of brain regions of relevance for memory and learning will be compared between the pre- and postoperative states.
    Time Frame
    Preoperatively, once at postoperative day 2-5 and after 3 month
    Secondary Outcome Measure Information:
    Title
    Cognitive testing
    Description
    Postoperative cognitive test battery according to the ISPOCD protocol, see Moller JT et al, Lancet 1998.
    Time Frame
    Preoperatively and after 3 month
    Title
    Inflammatory biomarkers
    Description
    Inflammatory biomarkers and genetic analysis of inflammatory biomarkers in blood.
    Time Frame
    Preoperatively, once at postoperative day 2-5 and after 3 month, i.e. at the same time as the PET investigation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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. Presumed uncooperativeness or legal incapacity. Preoperative or later postoperative B-hemoglobin < 90 g/L.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lars I Eriksson, MD,PhD, Professor
    Organizational Affiliation
    Karolinska University Hospital and Karolinska Institutet
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery

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