The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium

Postoperative Delirium Clinical Trial

Official title:

The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04027751
• Other study ID #: 04719372
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: March 2020
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of Tropisetron in preventing emergence delirium.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1508
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Postoperative Delirium

Intervention

Drug:
• Tropisetron
Investigators administrated intravenously Tropisetron 5mg before anesthesia induction
• Placebos
Investigators administrated intravenously 0.9% saline solution as a placebo

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: 15min after excubation; 30min after excubation; At discharge from post-anesthesia care unit (PACU)	Until the end of post-anesthesia care unit stay, assessed up to 1 hour
Secondary	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
Secondary	Incidence of postoperative nausea and vomiting		Within 3 days after surgery
Secondary	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
Secondary	Length of Hospital stay		From the date of admission until discharged from hospital, up to 30 days
Secondary	Adverse events	Other adverse events within 3 days after surgery were noted	Within 3 days after surgery