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Intraoperative Sedation and Postoperative Delirium

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ClinicalTrials.gov Identifier: NCT02573558
Recruitment Status : Completed
First Posted : October 12, 2015
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Orthopedics Drug: Dexmedetomidine Drug: Propofol

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Study Type : Observational
Actual Enrollment : 855 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prevalence of Postoperative Delirium According to the Use of Dexmedetomidine or Propofol in Elderly Patients Undergoing Orthopedic Surgery: Retrospective Study
Study Start Date : October 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort Intervention/treatment
DEX
patients who received dexmedetomidine during the operation
Drug: Dexmedetomidine
PPF
patients who received propofol during the operation
Drug: Propofol



Primary Outcome Measures :
  1. delirium [ Time Frame: within 7 day postoperatively ]

Secondary Outcome Measures :
  1. Wound infection [ Time Frame: within 7 day postoperatively ]
  2. Pulmonary thromboembolism [ Time Frame: within 7 day postoperatively ]
  3. Hospital stay [ Time Frame: through study completion, an average of 7days ]

Other Outcome Measures:
  1. Myocardial ischemia [ Time Frame: within 7 day postoperatively ]
  2. Renal failure [ Time Frame: within 7 day postoperatively ]
  3. Hepatic failure [ Time Frame: within 7 day postoperatively ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who underwent orthopedic surgery under regional anesthesia, and age of 65 years or greater
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573558


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of
Sponsors and Collaborators
Seoul National University Bundang Hospital
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Responsible Party: Hyo-Seok Na, Associate Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02573558    
Other Study ID Numbers: B-1510/318-104
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action