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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Delirium
• Intervention / Treatment: Drug: modified Tian Wang Bu Xin Dan hydrogel patch; Other: placebo patch

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Weidong Mi, PhD; Phone Number: 8613381082966; Email: wwdd1962@aliyun.com
• Study Contact Backup: Name: Chunlei Ouyang, PhD; Phone Number: +8618810300815; Email: ouyangchunlei@gmail.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Fifth Medical Center of Chinese PLA General Hospital
    • Contact: Yingqun Yu, PhD; Phone Number: 8613521558519; Email: yuyingqun@sohu.com
  • Beijing, China
    • Recruiting
    • First Medical center of Chinese PLA General Hospital
    • Contact: Weidong Mi, PhD; Phone Number: +8613381082966; Email: wwdd1962@aliyun.com
  • Beijing, China
    • Recruiting
    • Fourth Medical center of Chinese PLA General Hospital
    • Contact: Mengmeng Li, PhD; Phone Number: 8613401000778; Email: mmli304@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: modified Cheonwangbosimdan Hydrogel patch; Group receiving modified Cheonwangbosimdan Hydrogel patch	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 Names: modified Cheonwangbosimdan hydrogel patch
Placebo Comparator: Placebo patch; Group receiving placebo patch	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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: TWBXDPOD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No