Modified Tian Wang Bu Xin Dan Hydrogel Patch in Preventing Postoperative Delirium in Elderly Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Modified Tian Wang Bu Xin Dan Hydrogel Patch in Preventing Postoperative Delirium in Elderly Patients: A Muticenter Randomised Control Trial

Conditions
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Postoperative Delirium

Intervention / Treatment
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* Drug: modified Tian Wang Bu Xin Dan hydrogel patch
* Other: placebo patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients' age ≥70 years; Underwent elective non-cardiac surgery (including Orthopedics, thoracic, urology, general surgery patients)under general anesthesia ; Exclusion Criteria: History of neuropsychiatric diseases including delirium, mental disorders, Parkinson, dementia, etc.; The operation was cancelled due to various reasons after the patient was enrolled; severe liver disease; severe renal dysfunction defined as either having creatinine clearance < 30 ml/min or being dialysis-dependent; Patients who undergo second operation in a short period; Past 30-day prescribed use of sedative-hypnotics for the indication of insomnia; History of alcohol abuse or a history of drug dependence; Cannot with the completion of tests of cognitive function; Known allergy to skin patch; Treatment site has active skin lesion or inflammation; Refused to participate in the study.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: modified Cheonwangbosimdan Hydrogel patch<br>Group receiving modified Cheonwangbosimdan Hydrogel patch | Drug: modified Tian Wang Bu Xin Dan hydrogel patch<br>* 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)<br>* Other names: modified Cheonwangbosimdan hydrogel patch;|
| Placebo Comparator: Placebo patch<br>Group receiving placebo patch | Other: placebo patch<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |