Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery

Phase 4

Completed

• Conditions: Surgery; Anesthesia; Cognitive Disorders; Neurogenic Inflammation
• Interventions: Radiation: Positron emission tomography (PET) using [11C]PBR28

• Registration Number: NCT01881646
• Lead Sponsor: Karolinska University Hospital

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-19
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Binding of the PET probe [11C]PBR28	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 Outcome Measures

Name	Time	Method
Cognitive testing	Preoperatively and after 3 month	Postoperative cognitive test battery according to the ISPOCD protocol, see Moller JT et al, Lancet 1998.
Inflammatory biomarkers	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.