Minocycline Attenuate Postoperative Cognitive Dysfunction and Delirium

Phase 3

• Conditions: Prostate Cancer; Carcinoma of the Rectum; Colon Cancer; Renal Carcinoma
• Interventions: Drug: Placebo; Drug: Minocycline

• Registration Number: NCT02928692
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-06
• Study First Posted: 2016-10-10
• Study Start: 2016-11
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-25
• Last Update Posted: 2020-01-28
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 750

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo administered before surgery
Minocycline	Minocycline	Minocycline was administrated before surgery

Primary Outcome Measures

Name	Time	Method
POD incidence	1 to 5 days after surgery
POCD incidence 7 days (or before leaving hospital) after surgery	7 days (or before leaving hospital)

Secondary Outcome Measures

Name	Time	Method
POCD incidence 2 months after surgery	2 months after surgery

Trial Locations

Locations (5)

Shanghai Pudong New Area Dongming Community Health Care Center; 🇨🇳 Shanghai, China

Scales; 🇨🇳 Shanghai, Shanghai, China

Shanghai Pudong Hospital; 🇨🇳 Shanghai, China

Shanghai Pudong New Area people's Hopsital; 🇨🇳 Shanghai, China

Shanghai Tenth Hospital; 🇨🇳 Shanghai, China