Status:
UNKNOWN
The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium
Lead Sponsor:
Beijing Chao Yang Hospital
Conditions:
Emergence Delirium
Postoperative Delirium
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 o...
Eligibility Criteria
Inclusion
- Written consent given
- Scheduled to undergo elective non-cardiac surgeries under general anesthesia
- ASA Physical Score I-III
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2022
Estimated Enrollment :
1508 Patients enrolled
Trial Details
Trial ID
NCT04027751
Start Date
August 1 2019
End Date
March 31 2022
Last Update
March 11 2020
Active Locations (1)
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1
Beijing Chaoyang Hospital, Capital Medical University
Beijing, China, 100020