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

Postoperative Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04947761
• Other study ID #: TWBXDPOD
• Status: Recruiting
• Phase: Phase 4
• Start date: July 13, 2021
• Est. completion date: December 2022

Study information

• Verified date: August 2021
• Source: Chinese PLA General Hospital
• Contact: Weidong Mi, PhD
• Phone: 8613381082966
• Email: wwdd1962[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

1. Patients' age =70 years;

2. Underwent elective non-cardiac surgery (including Orthopedics, thoracic, urology, general surgery patients)under general anesthesia ;

Exclusion Criteria:

1. History of neuropsychiatric diseases including delirium, mental disorders, Parkinson, dementia, etc.;

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.

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

Drug:
• 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)

Other:
• 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)

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in biological markers (1)	Plasma levels of CXCL13	Baseline and 1 day after surgery
Secondary	Change in biological markers (2)	Plasma levels of S100B	Baseline and 1 day after surgery
Secondary	STOP-Bang score	STOP-BANG questionnaire	Baseline
Secondary	Pittsburgh Sleep Quality Index	The PSQI is filled out by the patient and assesses patient sleep quality.	Baseline and day 3 postoperatively