Back to resultsProbiotics Attenuate Postoperative Cognition Decline
Primary Purpose
Necrosis of Femoral Head, Knee Osteoarthritis, Fracture of Neck of Femur
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bifidobacterium triple live capsule
Placebos
Sponsored by
About this trial
This is an interventional prevention trial for Necrosis of Femoral Head focused on measuring postoperative cognitive dysfunction, postopeartive delirium, Probiotics
Eligibility Criteria
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
Sites / Locations
- Renji HospitalRecruiting
- Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western MedicineRecruiting
- Jin Cheng people's hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotic group
Placebo group
Arm 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.
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.
Outcomes
Primary Outcome Measures
Incidence of POCD 7days after surgery
Secondary Outcome Measures
Incidence of POCD 1 month after operation
Incidence of POD 7 days after surgery
Use the CAM scale to assess whether a patient has postoperative delirium
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04017403
Brief Title
Probiotics Attenuate Postoperative Cognition Decline
Official Title
Probiotics Oral Administration Attenuate Postoperative Cognition Decline in Elderly Orthopedic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study was to evaluate whether perioperative probiotics can reduce the incidence of postoperative cognitive dysfunction and postoperative delirium.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrosis of Femoral Head, Knee Osteoarthritis, Fracture of Neck of Femur, Lumbar Disc Herniation
Keywords
postoperative cognitive dysfunction, postopeartive delirium, Probiotics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotic group
Arm Type
Experimental
Arm 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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Bifidobacterium triple live capsule
Other Intervention Name(s)
Peifei Kang Capsule
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Placebo
Intervention Description
Placebos were administrated as same as the bifidobacterium live capsule
Primary Outcome Measure Information:
Title
Incidence of POCD 7days after surgery
Time Frame
The seventh day after surgery
Secondary Outcome Measure Information:
Title
Incidence of POCD 1 month after operation
Time Frame
One month after surgery
Title
Incidence of POD 7 days after surgery
Description
Use the CAM scale to assess whether a patient has postoperative delirium
Time Frame
One day after surgery to the seventh day after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
tang ying, Bachelor
Phone
13918859887
Ext
18616514088
Email
421941497@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
su diansan, Doctor
Phone
18616514088
Ext
18616514088
Email
184872238@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
su diansan
Organizational Affiliation
RenJi Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
diansan su, Dr.
Phone
+862168383702
Email
diansansu@yahoo.com
Facility Name
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoxue Hu
Email
ykxiaoxue@126.com
Facility Name
Jin Cheng people's hospital
City
Jincheng
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinping Wang
12. IPD Sharing Statement
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Probiotics Attenuate Postoperative Cognition Decline
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