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

NCT04947761 | Unknown Phase 4

• 1 other identifier: TWBXDPOD
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Sleep Quality

  Baseline and 1,3 days after surgery

• Athens Insomnia Scale

  Baseline and 1,2,3 days after surgery

• Pain at rest using Numerical Rating Scale(NRS)

  postoperative days 1, 2, 3

• Total postoperative analgesic requirements

  First 48 hours postoperatively

• Change in biological markers (1)

  Baseline and 1 day after surgery

Study Arms (2)

modified Cheonwangbosimdan Hydrogel patch

EXPERIMENTAL

Group receiving modified Cheonwangbosimdan Hydrogel patch

Drug: modified Tian Wang Bu Xin Dan hydrogel patch

Placebo patch

PLACEBO COMPARATOR

Group receiving placebo patch

Other: placebo patch

Interventions

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)

Also known as: modified Cheonwangbosimdan hydrogel patch

modified Cheonwangbosimdan Hydrogel patch

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)

Placebo patch

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients' age ≥70 years;
• Underwent elective non-cardiac surgery (including Orthopedics, thoracic, urology, general surgery patients)under general anesthesia ;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (3)

Fifth Medical center of Chinese PLA General Hospital

Beijing, China

RECRUITING

First Medical center of Chinese PLA General Hospital

Beijing, China

RECRUITING

Fourth Medical center of Chinese PLA General Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Weidong Mi, PhD

  Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Weidong Mi, PhD

CONTACT

8613381082966; wwdd1962@aliyun.com

Chunlei Ouyang, PhD

CONTACT

+8618810300815; ouyangchunlei@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 1, 2021
• Study Start: July 13, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 5, 2021

Record last verified: 2021-08

Locations

CN (3)