Probiotics Attenuate Postoperative Cognition Decline

Knee Osteoarthritis Clinical Trial

Official title:

Probiotics Oral Administration Attenuate Postoperative Cognition Decline in Elderly Orthopedic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04017403
• Other study ID #: PAPOCD
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2022
• Source: RenJi Hospital
• Contact: tang ying, Bachelor
• Phone: 13918859887
• Email: 421941497[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

Inclusion Criteria:

1. . Age is greater than or equal to 65 years old

2. . Can communicate normally

3. . Selective knee ankle, hip replacement or lumbar open reduction and internal fixation under general anesthesia

4. . ASA graded at I-II level

5. . Patient or family informed consent

Exclusion Criteria:

1. . Have a brain disease, or have a history of brain disease

2. .MMSE check of less than 24 points.

3. . History of neurological and psychological disorders including AD, stroke, psychosis

4. . Serious hearing or visual impairment

5. . Preoperative systolic blood pressure >190mmhg, or diastolic blood pressure >100mmhg

6. . The patient or family refuses

Related Conditions & MeSH terms

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

Intervention

Drug:
• Bifidobacterium triple live capsule
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.
• Placebos
Placebos were administrated as same as the bifidobacterium live capsule

Locations

Country	Name	City	State
China	Jin Cheng people's hospital	Jincheng	Shanxi
China	Renji Hospital	Shanghai	Shanghai
China	Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of POCD 7days after surgery		The seventh day after surgery
Secondary	Incidence of POCD 1 month after operation		One month after surgery
Secondary	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