Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery

Surgery Clinical Trial

— POPE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881646
• Other study ID #: POPE
• Status: Completed
• Phase: Phase 4
• First received: June 13, 2013
• Last updated: January 10, 2017
• Start date: June 2013
• Est. completion date: February 2016

Study information

• Verified date: January 2017
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anesthesia
• Cognition Disorders
• Cognitive Disorders
• Inflammation
• Neurogenic Inflammation
• Surgery

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	University of Copenhagen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Cognitive testing	Postoperative cognitive test battery according to the ISPOCD protocol, see Moller JT et al, Lancet 1998.	Preoperatively and after 3 month	No
Secondary	Inflammatory biomarkers	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	No