Clinical Trial: Effects of Dexmedetomidine on Postoperative Cognitive Dysfunction During One-lung Ventilation in Elder Patients

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Effects of Dexmedetomidine on Postoperative Cognitive Dysfunction During One-lung Ventilation in Elder Patients -a Single-center, Randomized ,Double-blinded and Controlled Trial

Brief Summary: This study is to explore the effects of dexmedetomidine on postoperative cognitive dysfunction during one-lung ventilation in elder patients.

Detailed Summary:
Sponsor: Tang-Du Hospital

Current Primary Outcome:

  • The change in memory [ Time Frame: one day before operation, first day after operation ]
    The change in memory will be evaluated by Controlled Oral Word Association Test ,Semantic Fluency test
  • Cognitive function [ Time Frame: one day before operation, first day after operation ]
    Cognitive function will be evaluated by Mini-mentalStateExamination,Digit-Symbol Substitution Test ,Trail Making Test
  • Postoperative anxiety [ Time Frame: one day before operation, first day after operation ]
    Self-evaluation of Depression Symptoms form,Self-Rating Anxiety Scale,Visual analog scales


Original Primary Outcome:

  • The change in learning [ Time Frame: one day before operation , first day and seventh day after operation ]
    The change in learning will be evaluated by Rey Auditory Verbal Learning Test
  • The change in memory [ Time Frame: one day before operation, first day and seventh day after operation ]
    The change in memory will be evaluated by Rey Auditory Verbal Learning Test,Controlled Oral Word Association Test ,Semantic Fluency test ,
  • Cognitive function [ Time Frame: one day before operation, first day and seventh day after operation ]
    Cognitive function will be evaluated by Mini-mentalStateExamination,Digit-Symbol Substitution Test ,Trail Making Test , Grooved Pegboard Dominant Hand
  • Postoperative anxiety [ Time Frame: one day before operation, first day and seventh day after operation ]
    Self-evaluation of Depression Symptoms form,Self-Rating Anxiety Scale,Visual analog scales


Current Secondary Outcome:

  • Heart rate [ Time Frame: At the moment of entering operating room ,the moment of intubation，prior to one lung ventilation,10 minutes,30 minutes afer one lung ventilation,the end of operation and the moment of leaving the operating room ]
  • Bleeding volume [ Time Frame: At the beginning of operation,at the end of operation,up to 24 hours ]
  • Total volume of fluid [ Time Frame: At the beginning of operation,at the end of operation,up to 24 hours ]
  • Duration of one lung ventilation [ Time Frame: At the beginning of one lung ventilation,at the end of one lung ventilation,an expected average of 3 hours ]
  • The total dose of anaesthetic drugs [ Time Frame: At the beginning of surgery,at the end of surgery,up to 24 hours ]
  • The total dose of analgesic drugs [ Time Frame: During perioperative period,up to 7 days ]
  • Blood pressure [ Time Frame: At the moment of entering operating room ,the moment of intubation，prior to one lung ventilation,10 minutes,30 minutes afer one lung ventilation,the end of operation and the moment of leaving the operating room ]
  • Oxygen saturation [ Time Frame: At the moment of entering operating room ,the moment of intubation，prior to one lung ventilation,10 minutes,30 minutes afer one lung ventilation,the end of operation and the moment of leaving the operating room ]
  • End-tidal carbon dioxide [ Time Frame: At the moment of entering operating room ,the moment of intubation，prior to one lung ventilation,10 minutes,30 minutes afer one lung ventilation,the end of operation and the moment of leaving the operating room ]
  • Operation duration [ Time Frame: At the beginning of surgery,at the end of surgery,up to 24 hours ]


Original Secondary Outcome:

  • Variation degree of Heart rate [ Time Frame: Prior to surgery，prior to lung ventilation,10 minutes,30 minutes and 60 minutes afer lung ventilation,weaning,and postoperation ]
  • Airway pressure [ Time Frame: Prior to surgery，prior to lung ventilation,10 minutes,30 minutes and 60 minutes afer lung ventilation,weaning,and postoperation ]
    Variation degree of airway pressure
  • Variation degree of blood gas analysis [ Time Frame: Prior to surgery，prior to lung ventilation,10 minutes,30 minutes and 60 minutes afer lung ventilation,weaning,and postoperation ]
  • Bleeding volume [ Time Frame: At the beginning of surgery,at the end of surgery,up to 24 hours ]
  • Total volume of fluid [ Time Frame: At the beginning of surgery,at the end of surgery,up to 24 hours ]
  • Duration of one lung ventilation [ Time Frame: At the beginning of one lung ventilation,at the end of one lung ventilation,an expected average of 3 hours ]
  • Duration of two-lung ventilations [ Time Frame: At the beginning of two-lung ventilations,at the end of two-lung ventilations, an expected average of 3 hours ]
  • The total dose of anaesthetic drugs [ Time Frame: At the beginning of surgery,at the end of surgery,up to 24 hours ]
  • The total dose of analgesic drugs [ Time Frame: During perioperative period,up to 7 days ]
  • Variation degree of blood pressure [ Time Frame: Prior to surgery，prior to lung ventilation,10 minutes,30 minutes and 60 minutes afer lung ventilation,weaning,and postoperation ]
  • Oxygen saturation [ Time Frame: Prior to surgery，prior to lung ventilation,10 minutes,30 minutes and 60 minutes afer lung ventilation,weaning,and postoperation ]
  • End-tidal carbon dioxide [ Time Frame: Prior to surgery，prior to lung ventilation,10 minutes,30 minutes and 60 minutes afer lung ventilation,weaning,and postoperation ]


Information By: Tang-Du Hospital

Dates:
Date Received: April 29, 2014
Date Started: July 2014
Date Completion: December 2015
Last Updated: July 9, 2014
Last Verified: July 2014