Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the efficacy and safety of Tropisetron in preventing emergence delirium.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tropisetron | Experimental | Patients allocated to this arm will receive single dose of intravenous Tropisetron (5mg) before anesthesia induction. |
|
| Placebo | Placebo Comparator | Patients allocated to this arm will receive an identical volume of saline solution before anesthesia induction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tropisetron | Drug | Investigators administrated intravenously Tropisetron 5mg before anesthesia induction |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Until the end of post-anesthesia care unit stay, assessed up to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative delirium | Screening of the patients regarding a postoperative delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU) | Within 3 days after surgery |
| Incidence of postoperative nausea and vomiting |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang Hospital, Capital Medical University | Recruiting | Beijing | 100020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33790560 | Derived | 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. | |
| 33052400 | Derived | Sun 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077526 | Tropisetron |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebos | Drug | Investigators administrated intravenously 0.9% saline solution as a placebo |
|
| 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. | Within 3 days after surgery |
| Length of Hospital stay | 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 | Within 3 days after surgery |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |