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Effect of Preoperative Anxiety on Postoperative Delirium in Elderly Patients Undergoing Orthopaedic Surgery.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216615
Recruitment Status : Not yet recruiting
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Jin Dong Liu, Xuzhou Medical University

Brief Summary:
Postoperative delirium is a common and important complication in patients. The aim of this study was to investigate whether preoperative anxiety predicted onset of postoperative delirium in elderly patients undergoing orthopaedic surgery, so as to help develop preventive approaches.

Condition or disease Intervention/treatment
Delirium Anxiety Behavioral: preoperative anxiety

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Study Type : Observational
Estimated Enrollment : 290 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Preoperative Anxiety on Postoperative Delirium in Elderly Patients Undergoing Orthopaedic Surgery.
Estimated Study Start Date : January 4, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Delirium

Group/Cohort Intervention/treatment
patients with preoperative anxiety Behavioral: preoperative anxiety
patients who are anxious

patients without preoperative anxiety Behavioral: preoperative anxiety
patients who are anxious




Primary Outcome Measures :
  1. Incidence of postoperative delirium [ Time Frame: 5-day postoperative period ]
    postoperative delirium is diagnosed using CAM



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
290 elderly patients undergoing elective orthopaedic surgery in the Affiliated Hospital of Xuzhou Medical University.
Criteria

Inclusion Criteria:

  • aged 65 or older
  • patients undergoing elective orthopaedic surgery
  • ASA I-III

Exclusion Criteria:

  • history of craniocerebral trauma surgery or severe central nervous system disease
  • inability to read or understand the informed consent documents
  • too physically or psychologically ill
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Responsible Party: Jin Dong Liu, Principal Investigator, Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT04216615    
Other Study ID Numbers: XYFY-2019-0156
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Individual Participant Data(IPD) will be available when this trial is finished and the article have been published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Anxiety Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders