Minocycline Attenuate Postoperative Cognitive Dysfunction and Delirium

NCT02928692 | Unknown Phase 3

• 1 other identifier: 20158202
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 5

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.

Conditions

Prostate Cancer; Carcinoma of the Rectum; Colon Cancer; Renal Carcinoma

Keywords

Minocycline; Postoperative cognitive dysfunction; Postoperative delirium

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• POCD incidence 2 months after surgery

  2 months after surgery

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo administered before surgery

Drug: Placebo

Minocycline

EXPERIMENTAL

Minocycline was administrated before surgery

Drug: Minocycline

Volunteers

NO INTERVENTION

Health people for calculate the incidence of POCD

Interventions

Minocycline DRUG

Minocycline

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• Elder than 65 years old
• Speak Chinese Mandarin
• Signed the inform consent
• No major disease health people
• Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;

Sponsors & Collaborators

• RenJi Hospital: lead
• Shanghai 10th People's Hospital: collaborator
• Pudong New Area People's Hospital: collaborator
• Shanghai Pudong Hospital: collaborator
• Shanghai Pudong New Aera Dongming Community Health Care Center: collaborator

Study Sites (5)

Scales

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Shanghai Pudong Hospital

Shanghai, China

NOT YET RECRUITING

Shanghai Pudong New Area Dongming Community Health Care Center

Shanghai, China

RECRUITING

Shanghai Pudong New Area people's Hopsital

Shanghai, China

RECRUITING

Shanghai Tenth Hospital

Shanghai, China

RECRUITING

Related Publications (21)

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• American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. Postoperative delirium in older adults: best practice statement from the American Geriatrics Society. J Am Coll Surg. 2015 Feb;220(2):136-48.e1. doi: 10.1016/j.jamcollsurg.2014.10.019. Epub 2014 Nov 14. No abstract available.

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MeSH Terms

Conditions

Prostatic Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Carcinoma, Renal Cell; cyclopia sequence; Postoperative Cognitive Complications; Emergence Delirium

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Central Study Contacts

Diansan Su, Doctor

CONTACT

18616514088; diansansu@yahoo.com

Hui Li, Master Degree Candidate

CONTACT

15216711923; 56428923@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: October 10, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

CN (5)