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

NCT ID: NCT04969523

Last Updated: 2021-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-31

Study Completion Date

2022-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Postoperative Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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es-ketamine

es-ketamine 0.5mg/kg iv

Group Type EXPERIMENTAL

lobectomy

Intervention Type PROCEDURE

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

saline

iv saline with the same volume of es-ketamine

Group Type PLACEBO_COMPARATOR

lobectomy

Intervention Type PROCEDURE

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

Interventions

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lobectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhongnan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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S001

Identifier Type: -

Identifier Source: org_study_id

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