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Effect of Es-ketamine on Postoperative Delirium Among Old Patients With Lobectomy

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ClinicalTrials.gov Identifier: NCT04969523
Recruitment Status : Not yet recruiting
First Posted : July 20, 2021
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Zhongnan Hospital

Tracking Information
First Submitted Date  ICMJE May 19, 2021
First Posted Date  ICMJE July 20, 2021
Last Update Posted Date July 20, 2021
Estimated Study Start Date  ICMJE July 31, 2021
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2021)
  • Postoperative Delirium [ Time Frame: 7 days after operation ]
    Confusion Assessment Method (CAM) or CAM-ICU for patients
  • Postoperative Cognitive Assessment [ Time Frame: 7 days after operation ]
    Montreal Cognitive Assessment
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Es-ketamine on Postoperative Delirium Among Old Patients With Lobectomy
Official Title  ICMJE Effect of Es-ketamine on Postoperative Delirium Among Old Patients With Lobectomy: a Multicentre, Double-blind, Randomised Clinical Trial
Brief Summary The purpose of this study is the efficiency of es-ketamine on postoperative delirium among old patients with elective lobectomy
Detailed Description This study aimed to investigate the effect of IV es-ketamine vs saline on the incidence of postoperative delirium. It was hypothesized that IV es-ketamine would reduce the incidence of in-hospital delirium during cardiac surgery lobectomy
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Postoperative Delirium
Intervention  ICMJE Procedure: lobectomy
Intravenous es-ketamine 0.5mg/kg or saline during lobectomy
Study Arms  ICMJE
  • Experimental: es-ketamine
    es-ketamine 0.5mg/kg iv
    Intervention: Procedure: lobectomy
  • Placebo Comparator: saline
    iv saline with the same volume of es-ketamine
    Intervention: Procedure: lobectomy
Publications * Not Provided

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2021)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 60 years old; There is no limit on the gender, ASA (American Society of Anesthesiologists )Ⅰ-Ⅲ

Exclusion Criteria:

  • Emergency surgery, severe hepatic and renal dysfunction, shock or coma, psychiatric disease or central nervous system disorder or a history of long-term use of psychiatric medications, cognitive dysfunction, severe arrhythmia or bradycardia, ketamine allergy,drug abuse history and used other sedatives for nearly a week
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04969523
Other Study ID Numbers  ICMJE S001
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
Plan to Share IPD: No
Responsible Party Zhongnan Hospital
Study Sponsor  ICMJE Zhongnan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Zhongnan Hospital
Verification Date July 2021

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