Probiotics Attenuate Postoperative Cognition Decline

Study Overview
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Brief Summary
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The aim of this study was to evaluate whether perioperative probiotics can reduce the incidence of postoperative cognitive dysfunction and postoperative delirium.

Official Title
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Probiotics Oral Administration Attenuate Postoperative Cognition Decline in Elderly Orthopedic Patients

Conditions
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Necrosis of Femoral Head, Knee Osteoarthritis, Fracture of Neck of Femur, Lumbar Disc Herniation

Intervention / Treatment
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* Drug: Bifidobacterium triple live capsule
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: . Age is greater than or equal to 65 years old . Can communicate normally . Selective knee ankle, hip replacement or lumbar open reduction and internal fixation under general anesthesia . ASA graded at I-II level . Patient or family informed consent Exclusion Criteria: . Have a brain disease, or have a history of brain disease .MMSE check of less than 24 points. . History of neurological and psychological disorders including AD, stroke, psychosis . Serious hearing or visual impairment . Preoperative systolic blood pressure >190mmhg, or diastolic blood pressure >100mmhg . The patient or family refuses

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic group<br>The probiotic group was treated with Bifidobacterium tripleis,one day before surgery to the sixth day after surgerythe drug is taken orally, 4 capsules at a time, 2 times a day. | Drug: Bifidobacterium triple live capsule<br>* Bifidobacterium triple live capsules, indications for acute and chronic diarrhea and constipation caused by intestinal flora imbalance, can also be used for the treatment of mild to moderate acute diarrhea, chronic diarrhea and indigestion, bloating, and adjuvant treatment of intestinal flora Endotoxemia caused by disorders.<br>* Other names: Peifei Kang Capsule;|
| Placebo Comparator: Placebo group<br>The control group was given the same package of placebo,one day before surgery to the sixth day after surgery. The drug is taken orally, 4 capsules at a time, 2 times a day. | Drug: Placebos<br>* Placebos were administrated as same as the bifidobacterium live capsule<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of POCD 7days after surgery |  | The seventh day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of POCD 1 month after operation |  | One month after surgery | 
| Incidence of POD 7 days after surgery | Use the CAM scale to assess whether a patient has postoperative delirium | One day after surgery to the seventh day after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative cognitive dysfunction, postopeartive delirium, Probiotics