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Intraoperative Sedation and Postoperative Delirium

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. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date October 6, 2015
First Posted Date October 12, 2015
Last Update Posted Date April 6, 2016
Study Start Date October 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 7, 2015)
delirium [ Time Frame: within 7 day postoperatively ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 7, 2015)
  • Wound infection [ Time Frame: within 7 day postoperatively ]
  • Pulmonary thromboembolism [ Time Frame: within 7 day postoperatively ]
  • Hospital stay [ Time Frame: through study completion, an average of 7days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 7, 2015)
  • Myocardial ischemia [ Time Frame: within 7 day postoperatively ]
  • Renal failure [ Time Frame: within 7 day postoperatively ]
  • Hepatic failure [ Time Frame: within 7 day postoperatively ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Intraoperative Sedation and Postoperative Delirium
Official Title Prevalence of Postoperative Delirium According to the Use of Dexmedetomidine or Propofol in Elderly Patients Undergoing Orthopedic Surgery: Retrospective Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients who underwent orthopedic surgery under regional anesthesia, and age of 65 years or greater
Condition Orthopedics
Intervention
  • Drug: Dexmedetomidine
  • Drug: Propofol
Study Groups/Cohorts
  • DEX
    patients who received dexmedetomidine during the operation
    Intervention: Drug: Dexmedetomidine
  • PPF
    patients who received propofol during the operation
    Intervention: Drug: Propofol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 5, 2016)
855
Original Estimated Enrollment
 (submitted: October 7, 2015)
600
Actual Study Completion Date January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02573558
Other Study ID Numbers B-1510/318-104
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hyo-Seok Na, Seoul National University Bundang Hospital
Study Sponsor Seoul National University Bundang Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Seoul National University Bundang Hospital
Verification Date April 2016