Clinical trial NCT04947761: Modified Tian Wang Bu Xin Dan Hydrogel Patch in Preventing Postoperative Delirium in Elderly Patients
Official title: Modified Tian Wang Bu Xin Dan Hydrogel Patch in Preventing Postoperative Delirium in Elderly Patients: A Muticenter Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Delirium
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 200
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of inpatient post-operative delirium as measured using the 3D-confusion assessment method (3D-CAM)
timeFrame: Day 1 postoperatively
measure: Incidence of inpatient post-operative delirium as measured using the 3D-confusion assessment method (3D-CAM)
timeFrame: Day 2 postoperatively
measure: Incidence of inpatient post-operative delirium as measured using the 3D-confusion assessment method (3D-CAM)
timeFrame: Day 3 postoperatively
Secondary outcomes:
measure: Sleep Quality
timeFrame: Baseline and 1,3 days after surgery
measure: Athens Insomnia Scale
timeFrame: Baseline and 1,2,3 days after surgery
measure: Pain at rest using Numerical Rating Scale(NRS)
timeFrame: postoperative days 1, 2, 3
measure: Total postoperative analgesic requirements
timeFrame: First 48 hours postoperatively
measure: Change in biological markers (1)
timeFrame: Baseline and 1 day after surgery
measure: Change in biological markers (2)
timeFrame: Baseline and 1 day after surgery
measure: STOP-Bang score
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline and day 3 postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fifth Medical center of Chinese PLA General Hospital
city: Beijing
country: China
facility: First Medical center of Chinese PLA General Hospital
city: Beijing
country: China
facility: Fourth Medical center of Chinese PLA General Hospital
Study officials:
affiliation: Chinese PLA General Hospital
name: Weidong Mi, PhD
role: STUDY_DIRECTOR
References: