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Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01881646
Acronym
POPE
Enrollment
8
Registered
2013-06-19
Start date
2013-06-30
Completion date
2016-02-29
Last updated
2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Cognitive Disorders, Neurogenic Inflammation, Surgery

Keywords

Neuroinflammation, Postoperative cognitive dysfunction

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.

Interventions

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

Sponsors

University of Copenhagen
CollaboratorOTHER
Karolinska University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Binding of the PET probe [11C]PBR28Preoperatively, once at postoperative day 2-5 and after 3 monthPET imaging of brain regions of relevance for memory and learning will be compared between the pre- and postoperative states.

Secondary

MeasureTime frameDescription
Cognitive testingPreoperatively and after 3 monthPostoperative cognitive test battery according to the ISPOCD protocol, see Moller JT et al, Lancet 1998.
Inflammatory biomarkersPreoperatively, once at postoperative day 2-5 and after 3 month, i.e. at the same time as the PET investigationInflammatory biomarkers and genetic analysis of inflammatory biomarkers in blood.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026