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The purpose of this study is to determine whether preoperative administration of Modified Tian Wang Bu Xin Dan Hydrogel Patch prevents the incidence of postoperative delirium in elderly patients undergoing major surgery.
The Traditional Chinese Medicine (TCM) Tian Wang Bu Xin Dan (TWBXD, Cheonwangbosimdan), first recorded in Effective Formulae Handed Down for Generations ( Shi Yi De Xiao Fang) in 1337, is a herbal medicine that has been continuously utilized in Chinese medicine. It alleviates insomnia, anxiety, and palpitation by furnishing energy and stabilizing patients' mind. Cheonwangbosimdan can mitigate primary insomnia and secondary insomnia in patients with hyperthyroidism and menopause without severe side effects.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| modified Cheonwangbosimdan Hydrogel patch | Experimental | Group receiving modified Cheonwangbosimdan Hydrogel patch |
|
| Placebo patch | Placebo Comparator | Group receiving placebo patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified Tian Wang Bu Xin Dan hydrogel patch | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of inpatient post-operative delirium as measured using the 3D-confusion assessment method (3D-CAM) | Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily | Day 1 postoperatively |
| Incidence of inpatient post-operative delirium as measured using the 3D-confusion assessment method (3D-CAM) | Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily | Day 2 postoperatively |
| Incidence of inpatient post-operative delirium as measured using the 3D-confusion assessment method (3D-CAM) | Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily | Day 3 postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality | Objective sleep quality will be measured using a Fitbit Charge 3 activity monitor to be worn | Baseline and 1,3 days after surgery |
| Athens Insomnia Scale | using the Athens Insomnia Scale to test the subjective sleep quality of patients. The range were from 0-3. Total score < 4 means sleep well; total score =6 means suspicious of insomnia; total score > 6 means insomnia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weidong Mi, PhD | Contact | 8613381082966 | wwdd1962@aliyun.com | |
| Chunlei Ouyang, PhD | Contact | +8618810300815 | ouyangchunlei@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Weidong Mi, PhD | Chinese PLA General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fifth Medical center of Chinese PLA General Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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|
| placebo patch | Other | 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) |
|
| Baseline and 1,2,3 days after surgery |
| Pain at rest using Numerical Rating Scale(NRS) | NRS pain scores will also be measured at rest. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible). | postoperative days 1, 2, 3 |
| Total postoperative analgesic requirements | Amount of opioid (IV morphine or hydromorphone) and oral analgesics required for pain control, reported as overall morphine equivalents. | First 48 hours postoperatively |
| Change in biological markers (1) | Plasma levels of CXCL13 | Baseline and 1 day after surgery |
| Change in biological markers (2) | Plasma levels of S100B | Baseline and 1 day after surgery |
| STOP-Bang score | STOP-BANG questionnaire | Baseline |
| Pittsburgh Sleep Quality Index | The PSQI is filled out by the patient and assesses patient sleep quality. | Baseline and day 3 postoperatively |
| First Medical center of Chinese PLA General Hospital | Recruiting | Beijing | China |
|
| Fourth Medical center of Chinese PLA General Hospital | Recruiting | Beijing | China |
|
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |