The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium

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.

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).

Patients allocated to this arm will receive single dose of intravenous Tropisetron (5mg) before anesthesia induction.

Patients allocated to this arm will receive an identical volume of saline solution before anesthesia induction.

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)

Screening of the patients regarding a postoperative delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU)

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.

Inclusion Criteria: Written consent given Scheduled to undergo elective non-cardiac surgeries under general anesthesia ASA Physical Score I-III Exclusion Criteria: 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.

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.

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.