Modified Tian Wang Bu Xin Dan Hydrogel Patch in Preventing Postoperative Delirium in Elderly Patients
NCT ID: NCT04947761
Last Updated: 2021-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2021-07-13
2022-12-31
Brief Summary
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Detailed Description
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Tianwang Buxin Decoction has the same effect as Olanzapine for the treatment of delirium after hip joint replacement in falling-induced senile femoral neck fracture patients.
This study aim to evaluate the incidence of postoperative delirium in elderly patients treated with prophylactic Modified Cheonwangbosimdan Hydrogel Patch versus placebo patch.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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modified Cheonwangbosimdan Hydrogel patch
Group receiving modified Cheonwangbosimdan Hydrogel patch
modified Tian Wang Bu Xin Dan hydrogel patch
modified Cheonwangbosimdan hydrogel patch (one patch/24 hours) applied to Shenque point for 4 days (1 patch daily beginning 2 days preoperative, and continued at 1 patch daily until 2 days postoperatively)
Placebo patch
Group receiving placebo patch
placebo patch
placebo patch (one patch/24 hours) applied to Shenque point for 4 days (1 patch daily beginning 2 days preoperative, and continued at 1 patch daily until 2 days postoperatively)
Interventions
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modified Tian Wang Bu Xin Dan hydrogel patch
modified Cheonwangbosimdan hydrogel patch (one patch/24 hours) applied to Shenque point for 4 days (1 patch daily beginning 2 days preoperative, and continued at 1 patch daily until 2 days postoperatively)
placebo patch
placebo patch (one patch/24 hours) applied to Shenque point for 4 days (1 patch daily beginning 2 days preoperative, and continued at 1 patch daily until 2 days postoperatively)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Underwent elective non-cardiac surgery (including Orthopedics, thoracic, urology, general surgery patients)under general anesthesia ;
Exclusion Criteria
2. The operation was cancelled due to various reasons after the patient was enrolled;
3. severe liver disease; severe renal dysfunction defined as either having creatinine clearance \< 30 ml/min or being dialysis-dependent;
4. Patients who undergo second operation in a short period;
5. Past 30-day prescribed use of sedative-hypnotics for the indication of insomnia;
6. History of alcohol abuse or a history of drug dependence;
7. Cannot with the completion of tests of cognitive function;
8. Known allergy to skin patch;
9. Treatment site has active skin lesion or inflammation;
10. Refused to participate in the study.
70 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Weidong Mi
Director (Cheif expert of National key research and development program of China 2018YFC2001900)
Principal Investigators
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Weidong Mi, PhD
Role: STUDY_DIRECTOR
Chinese PLA General Hospital
Locations
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Fifth Medical center of Chinese PLA General Hospital
Beijing, , China
First Medical center of Chinese PLA General Hospital
Beijing, , China
Fourth Medical center of Chinese PLA General Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TWBXDPOD
Identifier Type: -
Identifier Source: org_study_id
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