Clinical trial NCT04027751: The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium
Official title: The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Emergence Delirium
Postoperative Delirium
Keywords: tropisetron
emergence delirium
postoperative delirium
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 1508
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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).

Eligibility 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.

Primary outcomes:
measure: Incidence of emergence delirium
timeFrame: Until the end of post-anesthesia care unit stay, assessed up to 1 hour
Secondary outcomes:
measure: Incidence of postoperative delirium
timeFrame: Within 3 days after surgery
measure: Incidence of postoperative nausea and vomiting
timeFrame: Within 3 days after surgery
measure: Postoperative Pain
timeFrame: Within 3 days after surgery
measure: Length of Hospital stay
timeFrame: From the date of admission until discharged from hospital, up to 30 days
measure: Adverse events
timeFrame: Within 3 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
Study officials:
References:
citation: 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.
citation: 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.