Emergence DeliriumPhase 4NCT04027751
The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium
A Phase 4 study testing Tropisetron in people with Emergence Delirium and Postoperative Delirium, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine the efficacy and safety of Tropisetron in preventing emergence delirium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergence Delirium, 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
- 1,508 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 31 Mar 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 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 non-cardiac surgeries under general anesthesia
- ASA Physical Score I-III
Who cannot join
- Patients with a history of neurological disease, such as Alzheimer disease.
- Patients with a history of psychiatric disease
- Patients with a medication history of antipsychotic drugs over the last 30 days prior to enrollment.
- Unable to complete neuropsychological testing including patients with severe visual or hearing impairment.
- the Montreal Cognitive Assessment (MoCA) scores below 10
- Patients who have severe intraoperative adverse events, such as cardiac arrest.
- Patients with contraindication of tropisetron.
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: The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium: A Randomized Controlled Trial
The purpose of this study is to determine the efficacy and safety of Tropisetron in preventing emergence delirium.
Read the detailed description
Delirium is a common complication during postoperative period, especially in elderly patients. The presence of postoperative delirium is independently associated with poor recovery, increased length of hospital stay, the development of long-term cognitive decline 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. This study aims to access the efficacy and safety of tropisetron in preventing emergence delirium.
To explore the results differences amongst different patients, subgroup analysis will be conducted according to: a. Age (older than 65 years versus 65 years or younger); b. Surgery type (major surgery versus minor surgery); c. Preoperative MoCA scores (>26 versus 18-26 versus 10-17).
- Conditions
- Emergence Delirium, Postoperative Delirium
- Being tested
- Tropisetron, Placebos
- Keywords
- tropisetron, emergence delirium, postoperative delirium
- Medical subject headings
- 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 induction
PlacebosDrug
Investigators administrated intravenously 0.9% saline solution as a placebo
| Study group | Role | What they receive |
|---|---|---|
| Tropisetron | Experimental | Patients allocated to this arm will receive single dose of intravenous Tropisetron (5mg) before anesthesia induction. Receives: Drug: Tropisetron |
| Placebo | Placebo comparator | Patients allocated to this arm will receive an identical volume of saline solution before anesthesia induction. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of emergence delirium
Screening of the patients regarding an emergence delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU). CAM-ICU is assessed at three different points of time:
- 15min after excubation
- 30min after excubation
- At discharge from post-anesthesia care unit (PACU)
Measured: Until the end of post-anesthesia care unit stay, assessed up to 1 hour
Secondary outcomes (5)
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 3 days after surgery
Incidence of postoperative nausea and vomiting
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 3 days after surgery
Length of Hospital stay
Measured: From the date of admission until discharged from hospital, up to 30 days
Adverse events
Other adverse events within 3 days after surgery were noted
Measured: Within 3 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 posted22 Jul 2019
- Study start1 Aug 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Emergence DeliriumStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,508 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
- NCT04027751
- Sponsor's protocol ID
- 04719372
- Status last verified
- Mar 2020
- First submitted
- 16 Jul 2019
- Last updated
- 11 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang X, Wu D, Wu AS, Wei CW, Gao JD. The Association of Insomnia with Depression and Anxiety Symptoms in Patients Undergoing Noncardiac Surgery. Neuropsychiatr Dis Treat. 2021 Mar 25;17:915-924. doi: 10.2147/NDT.S296986. eCollection 2021.
PubMed 33790560Sun Y, Lin D, Wang J, Geng M, Xue M, Lang Y, Cui L, Hao Y, Mu S, Wu D, Liang L, Wu A; Tropisetron and Delirium Group. Effect of Tropisetron on Prevention of Emergence Delirium in Patients After Noncardiac Surgery: A Trial Protocol. JAMA Netw Open. 2020 Oct 1;3(10):e2013443. doi: 10.1001/jamanetworkopen.2020.13443.
PubMed 33052400
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04027751
- Acronym / sponsor ID
- 04719372
- Conditions
- Emergence Delirium, Postoperative Delirium
- Keywords
- tropisetron, emergence delirium, postoperative delirium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,508 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 22 Jul 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 determine the efficacy and safety of Tropisetron in preventing emergence delirium.
Detailed description
Delirium is a common complication during postoperative period, especially in elderly patients. The presence of postoperative delirium is independently associated with poor recovery, increased length of hospital stay, the development of long-term cognitive decline 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. This study aims to access the efficacy and safety of tropisetron in preventing emergence delirium.
To explore the results differences amongst different patients, subgroup analysis will be conducted according to: a. Age (older than 65 years versus 65 years or younger); b. Surgery type (major surgery versus minor surgery); c. Preoperative MoCA scores (>26 versus 18-26 versus 10-17).
Study design
- Primary purpose
- Prevention
- 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 single dose of intravenous Tropisetron (5mg) before anesthesia induction. |
| Placebo | Placebo comparator | Drug: PlacebosPatients allocated to this arm will receive an identical volume of saline solution before anesthesia induction. |
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 non-cardiac surgeries under general anesthesia
- ASA Physical Score I-III
Key exclusion criteria (7 listed)
- Patients with a history of neurological disease, such as Alzheimer disease.
- Patients with a history of psychiatric disease
- Patients with a medication history of antipsychotic drugs over the last 30 days prior to enrollment.
- Unable to complete neuropsychological testing including patients with severe visual or hearing impairment.
- the Montreal Cognitive Assessment (MoCA) scores below 10
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 induction | Drug | Tropisetron |
| PlacebosInvestigators administrated intravenously 0.9% saline solution as a placebo | Drug | Placebo |
Primary outcome
Incidence of emergence delirium
Time frame: Until the end of post-anesthesia care unit stay, assessed up to 1 hour
Screening of the patients regarding an emergence delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU). CAM-ICU is assessed at three different points of time: 1. 15min after excubation 2. 30min after excubation 3. At discharge from post-anesthesia care unit (PACU)
5 secondary outcomes
Incidence of postoperative delirium
Time frame: Within 3 days after surgery
Incidence of postoperative nausea and vomiting
Time frame: Within 3 days after surgery
Postoperative Pain
Time frame: Within 3 days after surgery
Length of Hospital stay
Time frame: From the date of admission until discharged from hospital, up to 30 days
Adverse events
Time frame: Within 3 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 11 Mar 2020.
- Derived from this study: PubMed 33790560Huang X, Wu D, Wu AS, Wei CW, Gao JD. The Association of Insomnia with Depression and Anxiety Symptoms in Patients Undergoing Noncardiac Surgery. Neuropsychiatr Dis Treat. 2021 Mar 25;17:915-924. doi: 10.2147/NDT.S296986. eCollection 2021.
- Derived from this study: PubMed 33052400Sun Y, Lin D, Wang J, Geng M, Xue M, Lang Y, Cui L, Hao Y, Mu S, Wu D, Liang L, Wu A; Tropisetron and Delirium Group. Effect of Tropisetron on Prevention of Emergence Delirium in Patients After Noncardiac Surgery: A Trial Protocol. JAMA Netw Open. 2020 Oct 1;3(10):e2013443. doi: 10.1001/jamanetworkopen.2020.13443.
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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 Emergence Delirium 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 7 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 11 Mar 2020. 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?
Incidence of emergence delirium (time frame: Until the end of post-anesthesia care unit stay, assessed up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04027751, which also lists 2 linked publications.
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 11 Mar 2020.