Minocycline Attenuate Postoperative Cognitive Dysfunction and Delirium (MAPOCD)

January 25, 2020 updated by: diansan su, RenJi Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

750

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Not yet recruiting
        • Shanghai Pudong Hospital
        • Contact:
          • Hongwei Duan
          • Phone Number: 189-1879-0035
      • Shanghai, China
        • Recruiting
        • Shanghai Pudong New Area Dongming Community Health Care Center
        • Contact:
          • Shifen Zhang
          • Phone Number: 13916517543
      • Shanghai, China
        • Recruiting
        • Shanghai Pudong New Area people's Hopsital
        • Contact:
      • Shanghai, China
        • Recruiting
        • Shanghai Tenth Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Scales
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Hui Li, M.S.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

For the placebo and minocycline group;

Inclusion Criteria:

  1. Elder than 65 years old
  2. Speak Chinese Mandarin
  3. Those who will undergo major general surgery like colorectal cancer excision, major urinary surgery like radical prostatectomy and radical nephrectomy
  4. Signed the inform consent
  5. American Society of Anesthesiologists classification I to III

Exclusion Criteria:

  1. Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;
  2. Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24;
  3. Severe audition or vision disorder;
  4. Unwillingness to comply with the protocol or procedures.
  5. Cannot communicated with Chinese Mandarin
  6. With severe skin disease
  7. Serious heart or liver or renal insufficiency patients
  8. Had surgery in the past 30 days
  9. Allergy to tetracycline or minocycline

For the health volunteers;

Inclusion Criteria:

  1. Elder than 65 years old
  2. Speak Chinese Mandarin
  3. Signed the inform consent
  4. No major disease health people

Exclusion Criteria:

  1. Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;
  2. Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24;
  3. Severe audition or vision disorder;
  4. Unwillingness to comply with the protocol or procedures.
  5. Cannot communicated with Chinese Mandarin
  6. Drug abuse, alcoholism
  7. Serious heart or liver or renal insufficiency patients
  8. Had surgery in the past 30 days
  9. Plan to undergo surgery in the following 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
POCD incidence 2 months after surgery
Time Frame: 2 months after surgery
2 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

October 5, 2016

First Submitted That Met QC Criteria

October 6, 2016

First Posted (Estimate)

October 10, 2016

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 25, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20158202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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