4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium

The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium

Study Description
Brief Summary:
The purpose of this study is to determine the efficacy and safety of Tropisetron in preventing emergence delirium.

Condition or disease Intervention/treatment Phase
Emergence Delirium Postoperative Delirium Drug: Tropisetron Drug: Placebos Phase 4

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).

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1508 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium: A Randomized Controlled Trial
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Tropisetron
Patients allocated to this arm will receive single dose of intravenous Tropisetron (5mg) before anesthesia induction.
 Drug: Tropisetron
Investigators administrated intravenously Tropisetron 5mg before anesthesia induction
Placebo Comparator: Placebo
Patients allocated to this arm will receive an identical volume of saline solution before anesthesia induction.
 Drug: Placebos
Investigators administrated intravenously 0.9% saline solution as a placebo
Outcome Measures
Primary Outcome Measures :
  1. Incidence of emergence delirium [ Time Frame: 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 Outcome Measures :
  1. Incidence of postoperative delirium [ Time Frame: 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)

  2. Incidence of postoperative nausea and vomiting [ Time Frame: Within 3 days after surgery ]
  3. Postoperative Pain [ Time Frame: 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.

  4. Length of Hospital stay [ Time Frame: From the date of admission until discharged from hospital, up to 30 days ]
  5. Adverse events [ Time Frame: Within 3 days after surgery ]
    Other adverse events within 3 days after surgery were noted


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Locations
Layout table for location information
China
Beijing Chaoyang Hospital, Capital Medical University Recruiting
Beijing, China, 100020
Contact: Anshi Wu    +8685231330    wuanshi1965@163.com   
Principal Investigator: Anshi Wu, MD         
Sponsors and Collaborators
Beijing Chao Yang Hospital
Tracking Information
First Submitted Date  ICMJE July 16, 2019
First Posted Date  ICMJE July 22, 2019
Last Update Posted Date March 11, 2020
Actual Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2019) 		Incidence of emergence delirium [ Time Frame: 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2019)
  • Incidence of postoperative delirium [ Time Frame: 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 [ Time Frame: Within 3 days after surgery ]
  • Postoperative Pain [ Time Frame: 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 [ Time Frame: From the date of admission until discharged from hospital, up to 30 days ]
  • Adverse events [ Time Frame: Within 3 days after surgery ]
    Other adverse events within 3 days after surgery were noted
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium
Official Title  ICMJE The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium: A Randomized Controlled Trial
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE
  • Emergence Delirium
  • Postoperative Delirium
Intervention  ICMJE
  • Drug: Tropisetron
    Investigators administrated intravenously Tropisetron 5mg before anesthesia induction
  • Drug: Placebos
    Investigators administrated intravenously 0.9% saline solution as a placebo
Study Arms  ICMJE
  • Experimental: Tropisetron
    Patients allocated to this arm will receive single dose of intravenous Tropisetron (5mg) before anesthesia induction.
    Intervention: Drug: Tropisetron
  • Placebo Comparator: Placebo
    Patients allocated to this arm will receive an identical volume of saline solution before anesthesia induction.
    Intervention: Drug: Placebos
Publications *
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 19, 2019) 		1508
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04027751
Other Study ID Numbers  ICMJE 04719372
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anshi Wu, Beijing Chao Yang Hospital
Study Sponsor  ICMJE Beijing Chao Yang Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Beijing Chao Yang Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯