The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium
Keywords
Abstract
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).
Dates
| Last Verified: | 02/29/2020 |
| First Submitted: | 07/15/2019 |
| Estimated Enrollment Submitted: | 07/18/2019 |
| First Posted: | 07/21/2019 |
| Last Update Submitted: | 03/08/2020 |
| Last Update Posted: | 03/10/2020 |
| Actual Study Start Date: | 07/31/2019 |
| Estimated Primary Completion Date: | 12/30/2021 |
| Estimated Study Completion Date: | 03/30/2022 |
Condition or disease
Intervention/treatment
Drug: Tropisetron
Drug: Placebo
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Tropisetron Patients allocated to this arm will receive single dose of intravenous Tropisetron (5mg) before anesthesia induction. | Drug: Tropisetron Investigators administrated intravenously Tropisetron 5mg before anesthesia induction |
| Placebo Comparator: Placebo Patients allocated to this arm will receive an identical volume of saline solution before anesthesia induction. | Drug: Placebo Investigators administrated intravenously 0.9% saline solution as a placebo |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: 1. Written consent given 2. Scheduled to undergo elective non-cardiac surgeries under general anesthesia 3. ASA Physical Score I-III Exclusion Criteria: 1. Patients with a history of neurological disease, such as Alzheimer disease. 2. Patients with a history of psychiatric disease 3. Patients with a medication history of antipsychotic drugs over the last 30 days prior to enrollment. 4. Unable to complete neuropsychological testing including patients with severe visual or hearing impairment. 5. the Montreal Cognitive Assessment (MoCA) scores below 10 6. Patients who have severe intraoperative adverse events, such as cardiac arrest. 7. Patients with contraindication of tropisetron. |
Outcome
Primary Outcome Measures
1. Incidence of emergence delirium [Until the end of post-anesthesia care unit stay, assessed up to 1 hour]
Secondary Outcome Measures
1. Incidence of postoperative delirium [Within 3 days after surgery]
2. Incidence of postoperative nausea and vomiting [Within 3 days after surgery]
3. Postoperative Pain [Within 3 days after surgery]
4. Length of Hospital stay [From the date of admission until discharged from hospital, up to 30 days]
5. Adverse events [Within 3 days after surgery]
