Emergence Delirium, Postoperative Delirium
Conditions
Keywords
tropisetron, emergence delirium, postoperative delirium
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).
Interventions
DRUGTropisetron
Investigators administrated intravenously Tropisetron 5mg before anesthesia induction
DRUGPlacebos
Investigators administrated intravenously 0.9% saline solution as a placebo
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of emergence delirium | Until the end of post-anesthesia care unit stay, assessed up to 1 hour | 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: 1. 15min after excubation 2. 30min after excubation 3. At discharge from post-anesthesia care unit (PACU) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative delirium | Within 3 days after surgery | Screening of the patients regarding a postoperative delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU) |
| Incidence of postoperative nausea and vomiting | Within 3 days after surgery | — |
| Postoperative Pain | Within 3 days after surgery | 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. |
| Length of Hospital stay | From the date of admission until discharged from hospital, up to 30 days | — |
| Adverse events | Within 3 days after surgery | Other adverse events within 3 days after surgery were noted |
Countries
China
Outcome results
None listed