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NCT04969523 Clinical Trial

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

Postoperative Delirium Clinical Trial

Official title:
Effect of Es-ketamine on Postoperative Delirium Among Old Patients With Lobectomy: a Multicentre, Double-blind, Randomised Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04969523
Other study ID # S001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 31, 2021
Est. completion date December 31, 2022

Study information
Verified date July 2021
Source Zhongnan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is the efficiency of es-ketamine on postoperative delirium among old patients with elective lobectomy

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 500
Est. completion date December 31, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - 60 years old; There is no limit on the gender, ASA (American Society of Anesthesiologists )?-? 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• lobectomy
Intravenous es-ketamine 0.5mg/kg or saline during lobectomy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Zhongnan Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative Delirium Confusion Assessment Method (CAM) or CAM-ICU for patients 7 days after operation
Primary Postoperative Cognitive Assessment Montreal Cognitive Assessment 7 days after operation
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