Minocycline Attenuate Postoperative Cognitive Dysfunction and Delirium

Study Overview
=================
Brief Summary
-----------------
Postoperative cognitive dysfunction (POCD) and postoperative delirium occurs mainly in aged patients. POCD and POD may increase the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective therapy method was proved. According to previous study, the neuroinflammation is the main reason both for POCD and POD. Minocycline is a tetracycline derivative. Due to it's lipophilic structure, it is easy to pass through blood brain barrier and attenuate neuroinflammation. It's neuroprotective effects has been proven in many experimental animal models such as Alzheimer's disease, Huntington's disease and Parkinson's syndrome. In present study, the investigators hypothesized that minocycline would attenuate the incidence of POCD and POD in the aged patients.

Official Title
-----------------
Minocycline Attenuate Postoperative Cognitive Dysfunction and Delirium: A Multicenter, Randomized, Double-Blind Clinical Trail

Conditions
-----------------
Prostate Cancer, Carcinoma of the Rectum, Colon Cancer, Renal Carcinoma

Intervention / Treatment
-----------------
* Drug: Minocycline
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
For the placebo and minocycline group; Inclusion Criteria: Elder than 65 years old Speak Chinese Mandarin Those who will undergo major general surgery like colorectal cancer excision, major urinary surgery like radical prostatectomy and radical nephrectomy Signed the inform consent American Society of Anesthesiologists classification I to III Exclusion Criteria: Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis; Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24; Severe audition or vision disorder; Unwillingness to comply with the protocol or procedures. Cannot communicated with Chinese Mandarin With severe skin disease Serious heart or liver or renal insufficiency patients Had surgery in the past 30 days Allergy to tetracycline or minocycline For the health volunteers; Inclusion Criteria: Elder than 65 years old Speak Chinese Mandarin Signed the inform consent No major disease health people Exclusion Criteria: Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis; Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24; Severe audition or vision disorder; Unwillingness to comply with the protocol or procedures. Cannot communicated with Chinese Mandarin Drug abuse, alcoholism Serious heart or liver or renal insufficiency patients Had surgery in the past 30 days Plan to undergo surgery in the following 3 months.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo administered before surgery | Drug: Placebo<br> <br> |
| Experimental: Minocycline<br>Minocycline was administrated before surgery | Drug: Minocycline<br> <br> |
| No Intervention: Volunteers<br>Health people for calculate the incidence of POCD | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POCD incidence 7 days (or before leaving hospital) after surgery |  | 7 days (or before leaving hospital) | 
| POD incidence |  | 1 to 5 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POCD incidence 2 months after surgery |  | 2 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Minocycline, Postoperative cognitive dysfunction, Postoperative delirium