A Pilot Trial Evaluating the Effect of Tropisetron on Postoperative Cognitive Dysfunction After Cardiac Surgery
NCT ID: NCT04195204
Last Updated: 2022-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
72 participants
INTERVENTIONAL
2020-11-01
2023-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Tropisetron
Patients allocated to this arm will receive intravenous Tropisetron (5mg) before anesthesia induction and once daily for 7 days after surgery.
Tropisetron
Investigators administrated intravenously Tropisetron 5mg before anesthesia and once daily for 7 days after surgery.
Placebo
Patients allocated to this arm will receive an identical volume of normal saline before anesthesia and once daily for 7 days after surgery.
Placebos
Investigators administrated intravenously saline solution as a placebo
Interventions
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Tropisetron
Investigators administrated intravenously Tropisetron 5mg before anesthesia and once daily for 7 days after surgery.
Placebos
Investigators administrated intravenously saline solution as a placebo
Eligibility Criteria
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Inclusion Criteria
2. Scheduled to undergo elective coronary artery bypass graft surgery under general anesthesia
3. ASA Physical Score I-IV
Exclusion Criteria
2. Contraindications to tropisetron.
3. 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.
4. History of neuropsychiatric diseases (such as dementia, epilepsy, Parkinson's disease, or schizophrenia).
5. History of antipsychotic drug use.
6. Pre-existing severe cognitive impairment at baseline, defined as a Montreal Cognitive Assessment (MoCA) score below 10
18 Years
ALL
No
Sponsors
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Beijing Chao Yang Hospital
OTHER
Responsible Party
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Anshi Wu
Head of Anesthesiology
Locations
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Beijing Chaoyang Hospital, Capital Medical University
Beijing, , China
Countries
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Facility Contacts
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Other Identifiers
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29847819
Identifier Type: -
Identifier Source: org_study_id
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