Postoperative Cognitive DysfunctionPhase 4NCT04195204
A Pilot Trial Evaluating the Effect of Tropisetron on Postoperative Cognitive Dysfunction After Cardiac Surgery
A Phase 4 study testing Tropisetron in people with Postoperative Cognitive Dysfunction and Postoperative Delirium, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
The purpose of this study is to assess the feasibility of a randomized, double-blind, placebo-controlled pilot trial evaluating the effect of tropisetron on prevention of postoperative cognitive dysfunction in patients after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Postoperative Delirium
- What is being tested?
- Tropisetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 30 Jun 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written consent given
- Scheduled to undergo elective coronary artery bypass graft surgery under general anesthesia
- ASA Physical Score I-IV
Who cannot join
- Inability to give informed consent.
- Contraindications to tropisetron.
- Critical preoperative state, including preoperative left ventricular ejection fraction less than 30%, ventricular tachycardia or ventricular fibrillation, preoperative cardiopulmonary resuscitation, preoperative intra-aortic balloon pump (IABP) or mechanical circulatory requirement.
- History of neuropsychiatric diseases (such as dementia, epilepsy, Parkinson's disease, or schizophrenia).
- History of antipsychotic drug use.
- Pre-existing severe cognitive impairment at baseline, defined as a Montreal Cognitive Assessment (MoCA) score below 10
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, 100020
Anshi Wu, +8685231330, wuanshi1965@163.com
Anshi Wu, MD
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Pilot Trial Evaluating the Effect of Tropisetron on Prevention of Postoperative Cognitive Dysfunction in Patients After Cardiac Surgery
The purpose of this study is to assess the feasibility of a randomized, double-blind, placebo-controlled pilot trial evaluating the effect of tropisetron on prevention of postoperative cognitive dysfunction in patients after cardiac surgery.
Read the detailed description
Postoperative cognitive dysfunction is a common complication during postoperative period，especially in elderly patients. It is characterized by cognitive decline, inattention and abnormal mental status following surgery. The presence of postoperative cognitive dysfunction is independently associated with poor recovery, increased hospital length of stay and increased mortality.
Tropisetron is a 5-HT3A receptor antagonist and is widely used to treat postoperative nausea and vomiting. Previous studies found that tropisetron has positive effect on cognitive function.
We have designed a randomized, double-blind, placebo-controlled trial to determine if tropisetron has a positive effect on postoperative coginitive function in patients after cardiac surgery. Several assessements which are related to delirium, cognitive function, sleep and functional status, blood sample collection and EEG recordings will be involved in the trial. Moreover, we have assumed a few long-term follow-ups.
Given the complexity of the trial, we have decided to implement a pilot trial to assess the feasibility and provide vital data for future formal trial.
- Being tested
- Tropisetron, Placebos
- Medical subject headings
- Postoperative Cognitive Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TropisetronDrug
Investigators administrated intravenously Tropisetron 5mg before anesthesia and once daily for 7 days after surgery.
PlacebosDrug
Investigators administrated intravenously saline solution as a placebo
| Study group | Role | What they receive |
|---|---|---|
| Tropisetron | Experimental | Patients allocated to this arm will receive intravenous Tropisetron (5mg) before anesthesia induction and once daily for 7 days after surgery. Receives: Drug: Tropisetron |
| Placebo | Placebo comparator | Patients allocated to this arm will receive an identical volume of normal saline before anesthesia and once daily for 7 days after surgery. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of tropisetron intervention on POCD in patients after cardiac surgery
The feasibility will mainly be determined by the percentage of participants who completed the whole study procedure from recruitment to the 1-month follow-up.
Measured: Within 30 days after surgery
Secondary outcomes (11)
Incidence of postoperative cognitive dysfunction
Screening of the patients regarding a POCD by Repeatable Battery Neuropsychological Status (RBANS). Besides, the changes in SCWT and IRI scores will be an additional indication of POCD.
Measured: One day before surgery, discharge from hospital and 1 month after surgery
Incidence of postoperative delirium
Screening of the patients regarding a postoperative delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU)
Measured: Within 7 days after surgery
Functional status measurement
Screening of the patients by Barthel Index scale ranging from 0 to 100, where less than 20 indicates total dependence, 20-35 scores indicate severe dependence, 40-55 scores indicate moderate dependence, equal or over 60 indicates mild dependency and 100 indicates independence.
Measured: One day before surgery and 1 month after surgery
EEG frequency spectrum
Electroencephalography will be recorded at different points of time as follows and EEG characteristics including power in alpha, beta, theta, delta, gamma, spectrum will be extracted using MATLAB:
- before anesthesia introduction
- during anesthesia
- 1 day after surgery
- 2 days after surgery
- 3 days after surgery
Measured: Within 3 days after surgery
Postoperative Pain
Visual Analogue Scale will be used to assess postoperative pain of patients. Numerical rating scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain.
Measured: Within 7 days after surgery
Sleep Quality
Sleep diary and subjective sleep quality scores（Visual Analogue Scale） will be used to assess postoperative sleep quality of patients within 7 days after surgery.
Chinese version of the Pittsburgh sleep quality index (PSQI) will be used to assess sleep quality and disturbances. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. The total score is between 0 and 21. The total score ≤ 5 indicates good sleep quality，> 5 indicates poor sleep quality. PSQI will be recorded at different points of time as follows：
- 1 day before surgery
- 30 days after surgery
Measured: Within 30 days after surgery
Incidence of postoperative nausea and vomiting
Measured: Within 7 days after surgery
Length of ICU stay
Measured: From the date of admission until discharged from ICU, up to 30 days
Length of Hospital stay
Measured: From the date of admission until discharged from hospital, up to 30 days
Incidence of major adverse cardiac and cerebral events
MACCE comprises all-cause mortality, myocardial infarction, repeat unplanned revascularization (surgical revision or percutaneous transluminal coronary angioplasty), and stroke
Measured: Within 30 days after surgery
Inflammatory biomarkers
lood samples will be collected at different points of time as follows:
- before anesthesia introduction
- 1 day after surgery
- 3 days after surgery
- 7 days after surgery Levels of serum biomarkers, including but not limited to, interleukin (IL)-1β, IL-6, IL-8, tumor necrosis factor (TNF)α, Interferon (IFN)γ, Tau, vascular endothelial growth factor (VEGF)D and brain-derived neurotrophic factor (BDNF) will be examined using these specimens
Measured: Within 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Nov 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anshi Wu, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195204
- Sponsor's protocol ID
- 29847819
- Status last verified
- Jan 2022
- First submitted
- 27 Nov 2019
- Last updated
- 5 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Pilot Trial Evaluating the Effect of Tropisetron on Prevention of Postoperative Cognitive Dysfunction in Patients After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04195204
- Acronym / sponsor ID
- 29847819
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 11 Dec 2019 (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 assess the feasibility of a randomized, double-blind, placebo-controlled pilot trial evaluating the effect of tropisetron on prevention of postoperative cognitive dysfunction in patients after cardiac surgery.
Detailed description
Postoperative cognitive dysfunction is a common complication during postoperative period，especially in elderly patients. It is characterized by cognitive decline, inattention and abnormal mental status following surgery. The presence of postoperative cognitive dysfunction is independently associated with poor recovery, increased hospital length of stay and increased mortality.
Tropisetron is a 5-HT3A receptor antagonist and is widely used to treat postoperative nausea and vomiting. Previous studies found that tropisetron has positive effect on cognitive function.
We have designed a randomized, double-blind, placebo-controlled trial to determine if tropisetron has a positive effect on postoperative coginitive function in patients after cardiac surgery. Several assessements which are related to delirium, cognitive function, sleep and functional status, blood sample collection and EEG recordings will be involved in the trial. Moreover, we have assumed a few long-term follow-ups.
Given the complexity of the trial, we have decided to implement a pilot trial to assess the feasibility and provide vital data for future formal trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tropisetron | Experimental | Drug: TropisetronPatients allocated to this arm will receive intravenous Tropisetron (5mg) before anesthesia induction and once daily for 7 days after surgery. |
| Placebo | Placebo comparator | Drug: PlacebosPatients allocated to this arm will receive an identical volume of normal saline before anesthesia and once daily for 7 days after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written consent given
- Scheduled to undergo elective coronary artery bypass graft surgery under general anesthesia
- ASA Physical Score I-IV
Key exclusion criteria (6 listed)
- Inability to give informed consent.
- Contraindications to tropisetron.
- Critical preoperative state, including preoperative left ventricular ejection fraction less than 30%, ventricular tachycardia or ventricular fibrillation, preoperative cardiopulmonary resuscitation, preoperative intra-aortic balloon pump (IABP) or mechanical circulatory requirement.
- History of neuropsychiatric diseases (such as dementia, epilepsy, Parkinson's disease, or schizophrenia).
- History of antipsychotic drug use.
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 |
|---|---|---|
| TropisetronInvestigators administrated intravenously Tropisetron 5mg before anesthesia and once daily for 7 days after surgery. | Drug | Tropisetron |
| PlacebosInvestigators administrated intravenously saline solution as a placebo | Drug | Placebo |
Primary outcome
The feasibility of tropisetron intervention on POCD in patients after cardiac surgery
Time frame: Within 30 days after surgery
The feasibility will mainly be determined by the percentage of participants who completed the whole study procedure from recruitment to the 1-month follow-up.
11 secondary outcomes
Incidence of postoperative cognitive dysfunction
Time frame: One day before surgery, discharge from hospital and 1 month after surgery
Incidence of postoperative delirium
Time frame: Within 7 days after surgery
Functional status measurement
Time frame: One day before surgery and 1 month after surgery
EEG frequency spectrum
Time frame: Within 3 days after surgery
Postoperative Pain
Time frame: Within 7 days after surgery
Sleep Quality
Time frame: Within 30 days after surgery
Incidence of postoperative nausea and vomiting
Time frame: Within 7 days after surgery
Length of ICU stay
Time frame: From the date of admission until discharged from ICU, up to 30 days
Length of Hospital stay
Time frame: From the date of admission until discharged from hospital, up to 30 days
Incidence of major adverse cardiac and cerebral events
Time frame: Within 30 days after surgery
Inflammatory biomarkers
Time frame: Within 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tropisetron in people with Postoperative Cognitive Dysfunction and Postoperative Delirium, run by Beijing Chao Yang Hospital at 1 site 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 3 inclusion and 6 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 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of tropisetron intervention on POCD in patients after cardiac surgery (time frame: Within 30 days after surgery). 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 Jan 2022.