Postoperative DeliriumPhase 4NCT04947761
Modified Tian Wang Bu Xin Dan Hydrogel Patch in Preventing Postoperative Delirium in Elderly Patients
A Phase 4 study testing modified Tian Wang Bu Xin Dan hydrogel patch in people with Postoperative Delirium, run by Chinese PLA General Hospital at 3 sites in China.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- modified Tian Wang Bu Xin Dan hydrogel patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 3 sitesChina
- Study dates
- 13 Jul 2021to Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients' age ≥70 years;
- Underwent elective non-cardiac surgery (including Orthopedics, thoracic, urology, general surgery patients)under general anesthesia ;
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Fifth Medical center of Chinese PLA General Hospital
Beijing
Yingqun Yu, PhD, 8613521558519, yuyingqun@sohu.com
- Recruiting
First Medical center of Chinese PLA General Hospital
Beijing
Weidong Mi, PhD, +8613381082966, wwdd1962@aliyun.com
- Recruiting
Fourth Medical center of Chinese PLA General Hospital
Beijing
Mengmeng Li, PhD, 8613401000778, mmli304@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Delirium
- Being tested
- modified Tian Wang Bu Xin Dan hydrogel patch, placebo patch
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified Tian Wang Bu Xin Dan hydrogel patchDrug
Also called modified Cheonwangbosimdan 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)
placebo patchOther
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)
| Study group | Role | What they receive |
|---|---|---|
| modified Cheonwangbosimdan Hydrogel patch | Experimental | Group receiving modified Cheonwangbosimdan Hydrogel patch Receives: Drug: modified Tian Wang Bu Xin Dan hydrogel patch |
| Placebo patch | Placebo comparator | Group receiving placebo patch Receives: Other: placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Day 3 postoperatively
Secondary outcomes (8)
Sleep Quality
Objective sleep quality will be measured using a Fitbit Charge 3 activity monitor to be worn
Measured: 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.
Measured: 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).
Measured: 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.
Measured: First 48 hours postoperatively
Change in biological markers (1)
Plasma levels of CXCL13
Measured: Baseline and 1 day after surgery
Change in biological markers (2)
Plasma levels of S100B
Measured: Baseline and 1 day after surgery
STOP-Bang score
STOP-BANG questionnaire
Measured: Baseline
Pittsburgh Sleep Quality Index
The PSQI is filled out by the patient and assesses patient sleep quality.
Measured: Baseline and day 3 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start13 Jul 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
- Investigators
- Weidong Mi, PhD, Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947761
- Sponsor's protocol ID
- TWBXDPOD
- Status last verified
- Aug 2021
- First submitted
- 24 Jun 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Tian Wang Bu Xin Dan Hydrogel Patch in Preventing Postoperative Delirium in Elderly Patients: A Muticenter Randomised Control Trial
- ClinicalTrials.gov ID
- NCT04947761
- Acronym / sponsor ID
- TWBXDPOD
- Conditions
- Postoperative Delirium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified Cheonwangbosimdan Hydrogel patch | Experimental | Drug: modified Tian Wang Bu Xin Dan hydrogel patchGroup receiving modified Cheonwangbosimdan Hydrogel patch |
| Placebo patch | Placebo comparator | Other: placebo patchGroup receiving placebo patch |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients' age ≥70 years;
- Underwent elective non-cardiac surgery (including Orthopedics, thoracic, urology, general surgery patients)under general anesthesia ;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified Tian Wang Bu Xin Dan hydrogel patchAlso: modified Cheonwangbosimdan hydrogel patchmodified 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) | Drug | modified Cheonwangbosimdan Hydrogel patch |
| placebo patchplacebo 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 |
Primary outcome
Incidence of inpatient post-operative delirium as measured using the 3D-confusion assessment method (3D-CAM)
Time frame: Day 1 postoperatively
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)
Time frame: Day 2 postoperatively
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)
Time frame: Day 3 postoperatively
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
8 secondary outcomes
Sleep Quality
Time frame: Baseline and 1,3 days after surgery
Athens Insomnia Scale
Time frame: Baseline and 1,2,3 days after surgery
Pain at rest using Numerical Rating Scale(NRS)
Time frame: postoperative days 1, 2, 3
Total postoperative analgesic requirements
Time frame: First 48 hours postoperatively
Change in biological markers (1)
Time frame: Baseline and 1 day after surgery
Change in biological markers (2)
Time frame: Baseline and 1 day after surgery
STOP-Bang score
Time frame: Baseline
Pittsburgh Sleep Quality Index
Time frame: Baseline and day 3 postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weidong Mi, PhD study director
Chinese PLA General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing modified Tian Wang Bu Xin Dan hydrogel patch in people with Postoperative Delirium, run by Chinese PLA General Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weidong Mi, PhD (8613381082966, wwdd1962@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of inpatient post-operative delirium as measured using the 3D-confusion assessment method (3D-CAM) (time frame: Day 1 postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.