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. 2016 Feb 22;2016(2):CD000521. doi: 10.1002/14651858.CD000521.pub3

NCT02213380.

Trial name or title Effect of Anesthesia on Post‐operative Delirium in Elderly Patients Undergoing Hip Fracture Surgery (RAGADelirium)
Methods RCT; open label; parallel assignment
Participants Older patients (≥ 65 years with hip fracture and planned hip fracture surgery
Interventions General anaesthesia versus regional anaesthesia
Outcomes Primary Outcome Measures: the incidence of postoperative cognitive dysfunction (POD) in 7 days postoperation [ Time Frame: in 7 days postoperation POD diagnosed with CAM
 
 Secondary Outcome Measures:
  • The type of delirium diagnosed in 7 days postoperation (time frame: 7 days postoperation). The type of delirium diagnosed with the Delirium Rating Scale‐Revised‐98 (DRS‐R‐98)

  • Acute pain score using visual analogue scale (VAS) (time frame: 7days postoperation)

  • Postoperative morbidity (time frame: up to hospital discharge or mortality postoperation) including chest infection, myocardial infarction, renal failure, gastrointestinal ileus and so on

  • Length of hospital stay (time frame: on the day of discharge from hospital)

  • Severity of delirium (time frame: 7 days postoperation). Severity of delirium was diagnosed with the DRS‐R‐98

  • Duration of delirium (time frame: 7 days postoperation) diagnosed with CAM

  • 30‐day mortality (time frame: 30 days after surgery)

  • 6 months incidence of delirium (time frame: 6 months after discharge) in clinic or at their residence, diagnosed with CAM

  • 12 months incidence of delirium (time frame: 12 months after discharge) in clinic or at their residence, diagnosed with CAM

  • 6 months quality of life (time frame: 6 months after discharge) using SF‐36 questionnaire

  • 12 months quality of life (time frame: 12 months after discharge) using SF‐36 questionnaire

Starting date October 2014
Contact information Contact: Ting LI, M.D.: liting1021@aliyun.com and Contact: Sishi Chen: chensishiwz@163.com
Notes