Probiotics Attenuate Postoperative Cognition Decline

Shanghai Jiao Tong University

Status: Unknown

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

Treatments: Drug: Bifidobacterium triple live capsule; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT04017403

PAPOCD

Details and patient eligibility

About

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

Enrollment: 220 estimated patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

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.

Treatment:

Drug: Bifidobacterium triple live capsule

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebos