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

Primary Purpose

Postoperative Delirium

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
modified Tian Wang Bu Xin Dan hydrogel patch
placebo patch
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Delirium

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fifth Medical center of Chinese PLA General HospitalRecruiting
  • First Medical center of Chinese PLA General HospitalRecruiting
  • Fourth Medical center of Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

modified Cheonwangbosimdan Hydrogel patch

Placebo patch

Arm Description

Group receiving modified Cheonwangbosimdan Hydrogel patch

Group receiving placebo patch

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Sleep Quality
Objective sleep quality will be measured using a Fitbit Charge 3 activity monitor to be worn
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.
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).
Total postoperative analgesic requirements
Amount of opioid (IV morphine or hydromorphone) and oral analgesics required for pain control, reported as overall morphine equivalents.
Change in biological markers (1)
Plasma levels of CXCL13
Change in biological markers (2)
Plasma levels of S100B
STOP-Bang score
STOP-BANG questionnaire
Pittsburgh Sleep Quality Index
The PSQI is filled out by the patient and assesses patient sleep quality.

Full Information

First Posted
June 24, 2021
Last Updated
August 31, 2021
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04947761
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 13, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
modified Cheonwangbosimdan Hydrogel patch
Arm Type
Experimental
Arm Description
Group receiving modified Cheonwangbosimdan Hydrogel patch
Arm Title
Placebo patch
Arm Type
Placebo Comparator
Arm Description
Group receiving placebo patch
Intervention Type
Drug
Intervention Name(s)
modified Tian Wang Bu Xin Dan hydrogel patch
Other Intervention Name(s)
modified Cheonwangbosimdan hydrogel patch
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
placebo patch
Intervention Description
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)
Primary Outcome Measure Information:
Title
Incidence of inpatient post-operative delirium as measured using the 3D-confusion assessment method (3D-CAM)
Description
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
Time Frame
Day 1 postoperatively
Title
Incidence of inpatient post-operative delirium as measured using the 3D-confusion assessment method (3D-CAM)
Description
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
Time Frame
Day 2 postoperatively
Title
Incidence of inpatient post-operative delirium as measured using the 3D-confusion assessment method (3D-CAM)
Description
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
Time Frame
Day 3 postoperatively
Secondary Outcome Measure Information:
Title
Sleep Quality
Description
Objective sleep quality will be measured using a Fitbit Charge 3 activity monitor to be worn
Time Frame
Baseline and 1,3 days after surgery
Title
Athens Insomnia Scale
Description
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.
Time Frame
Baseline and 1,2,3 days after surgery
Title
Pain at rest using Numerical Rating Scale(NRS)
Description
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).
Time Frame
postoperative days 1, 2, 3
Title
Total postoperative analgesic requirements
Description
Amount of opioid (IV morphine or hydromorphone) and oral analgesics required for pain control, reported as overall morphine equivalents.
Time Frame
First 48 hours postoperatively
Title
Change in biological markers (1)
Description
Plasma levels of CXCL13
Time Frame
Baseline and 1 day after surgery
Title
Change in biological markers (2)
Description
Plasma levels of S100B
Time Frame
Baseline and 1 day after surgery
Title
STOP-Bang score
Description
STOP-BANG questionnaire
Time Frame
Baseline
Title
Pittsburgh Sleep Quality Index
Description
The PSQI is filled out by the patient and assesses patient sleep quality.
Time Frame
Baseline and day 3 postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weidong Mi, PhD
Phone
8613381082966
Email
wwdd1962@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chunlei Ouyang, PhD
Phone
+8618810300815
Email
ouyangchunlei@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weidong Mi, PhD
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Fifth Medical center of Chinese PLA General Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingqun Yu, PhD
Phone
8613521558519
Email
yuyingqun@sohu.com
Facility Name
First Medical center of Chinese PLA General Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong Mi, PhD
Phone
+8613381082966
Email
wwdd1962@aliyun.com
Facility Name
Fourth Medical center of Chinese PLA General Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mengmeng Li, PhD
Phone
8613401000778
Email
mmli304@163.com

12. IPD Sharing Statement

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

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