NCT04027751

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,508

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2019

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

2.4 years

First QC Date

July 16, 2019

Last Update Submit

March 9, 2020

Conditions

Emergence DeliriumPostoperative Delirium

Keywords

tropisetronemergence deliriumpostoperative delirium

Outcome Measures

Primary Outcomes (1)

  • 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: 1. 15min after excubation 2. 30min after excubation 3. At discharge from post-anesthesia care unit (PACU)

    Until the end of post-anesthesia care unit stay, assessed up to 1 hour

Secondary Outcomes (5)

  • Incidence of postoperative delirium

    Within 3 days after surgery

  • Incidence of postoperative nausea and vomiting

    Within 3 days after surgery

  • Postoperative 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

    Within 3 days after surgery

Study Arms (2)

Tropisetron

EXPERIMENTAL

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

Drug: Tropisetron

Placebo

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

TropisetronDRUG

Investigators administrated intravenously Tropisetron 5mg before anesthesia induction

Tropisetron
PlacebosDRUG

Investigators administrated intravenously 0.9% saline solution as a placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written consent given
  • Scheduled to undergo elective non-cardiac surgeries under general anesthesia
  • ASA Physical Score I-III

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Chaoyang Hospital, Capital Medical University

Beijing, 100020, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 33790560DERIVED

  • 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.

    PMID: 33052400DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

Tropisetron

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesiology

Study Record Dates

First Submitted

July 16, 2019

First Posted

July 22, 2019

Study Start

August 1, 2019

Primary Completion

December 31, 2021

Study Completion

March 31, 2022

Last Updated

March 11, 2020

Record last verified: 2020-03

Locations

CN(1)