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Completed

NCT Number: NCT01881646

Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery

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

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Key information

Conditions

Anesthesia Cognition Disorders Cognitive Disorders Cognitive Dysfunction Inflammation Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurogenic Inflammation Neuroinflammatory Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications Surgery

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Radiation

Primary outcomes

  1. 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

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • University of Copenhagen

Registry information

Acronym: POPE

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 19, 2013
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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