Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery

NCT01881646 | Completed Phase 4

• 1 other identifier: POPE
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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

Conditions

Anesthesia; Surgery; Neurogenic Inflammation; Cognitive Disorders

Keywords

Neuroinflammation; Postoperative cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

• 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

Study Arms (1)

Positron emission tomography (PET)

EXPERIMENTAL

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

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

Interventions

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

Positron emission tomography (PET)

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska University Hospital: lead
• University of Copenhagen: collaborator

MeSH Terms

Conditions

Neurogenic Inflammation; Cognitive Dysfunction; Neuroinflammatory Diseases; Postoperative Cognitive Complications

Interventions

Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole; (methyl-(11)C)N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Postoperative Complications

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Lars I Eriksson, MD,PhD, Professor

  Karolinska University Hospital and Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 19, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: January 11, 2017

Record last verified: 2017-01