MAPOCD: Minocycline Attenuate Postoperative Cognitive Dysfunction and Delirium

Sponsor

RenJi Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02928692

Collaborator

Shanghai 10th People's Hospital (Other), Pudong New Area People's Hospital (Other), Shanghai Pudong Hospital (Other), Shanghai Pudong New Aera Dongming Community Health Care Center (Other)

750

Enrollment

Locations

Arms

Anticipated Duration (Months)

150

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Carcinoma of the Rectum Colon Cancer Renal Carcinoma	Drug: Minocycline Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

750 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo administered before surgery	Drug: Placebo
Experimental: Minocycline Minocycline was administrated before surgery	Drug: Minocycline
No Intervention: Volunteers Health people for calculate the incidence of POCD

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Placebo administered before surgery

Drug: Placebo

Experimental: Minocycline

Minocycline was administrated before surgery

Drug: Minocycline

No Intervention: Volunteers

Health people for calculate the incidence of POCD

Outcome Measures

Primary Outcome Measures

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

POCD incidence 2 months after surgery [2 months after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scales	Shanghai	Shanghai	China	200127
2	Shanghai Pudong Hospital	Shanghai		China
3	Shanghai Pudong New Area Dongming Community Health Care Center	Shanghai		China
4	Shanghai Pudong New Area people's Hopsital	Shanghai		China
5	Shanghai Tenth Hospital	Shanghai		China