Intraoperative Sedation and Postoperative Delirium

April 5, 2016 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital

Prevalence of Postoperative Delirium According to the Use of Dexmedetomidine or Propofol in Elderly Patients Undergoing Orthopedic Surgery: Retrospective Study

Delirium are common after orthopedic surgery in the elderly and are directly associated with loss of independence, reduction in the quality of life and increased mortality. The cause of postoperative delirium still remains unclear and may be multifactorial. The aim of this retrospective study is to examine prevalence of postoperative delirium according to the use of dexmedetomidine or propofol in elderly patients undergoing orthopedic surgery under regional anesthesia.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

855

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who underwent orthopedic surgery under regional anesthesia, and age of 65 years or greater

Description

Inclusion Criteria:

  • Patients who underwent orthopedic surgery under regional anesthesia
  • age of 65 years or greater

Exclusion Criteria:

  • General anesthesia
  • age < 65 years
  • central nervous system disease, including dementia and Parkinson's disease
  • Patients who were not received sedation with propofol or dexmedetomidine during the operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DEX
patients who received dexmedetomidine during the operation
PPF
patients who received propofol during the operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
delirium
Time Frame: within 7 day postoperatively
within 7 day postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Wound infection
Time Frame: within 7 day postoperatively
within 7 day postoperatively
Pulmonary thromboembolism
Time Frame: within 7 day postoperatively
within 7 day postoperatively
Hospital stay
Time Frame: through study completion, an average of 7days
through study completion, an average of 7days

Other Outcome Measures

Outcome Measure
Time Frame
Myocardial ischemia
Time Frame: within 7 day postoperatively
within 7 day postoperatively
Renal failure
Time Frame: within 7 day postoperatively
within 7 day postoperatively
Hepatic failure
Time Frame: within 7 day postoperatively
within 7 day postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

October 6, 2015

First Submitted That Met QC Criteria

October 7, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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