Effects of Dexmedetomidine on Postoperative Cognitive Dysfunction During One-lung Ventilation in Elder Patients -a Single-center, Randomized ,Double-blinded and Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium
- Conditions
- Postoperative Confusion
- Sponsor
- Tang-Du Hospital
- Enrollment
- 120
- Primary Endpoint
- The change in memory
- Last Updated
- 11 years ago
Overview
Brief Summary
This study is to explore the effects of dexmedetomidine on postoperative cognitive dysfunction during one-lung ventilation in elder patients.
Investigators
YangLu
physician
Tang-Du Hospital
Eligibility Criteria
Inclusion Criteria
- •Written informed consent.
- •Ongoing one-lung ventilation surgery.
- •American Society of Anesthesiologists class I to III.
- •Aged between 55 and 75 years old.
- •Body Mass Index between 18 and 25 kg/m2.
Exclusion Criteria
- •Systolic blood pressure more than 180 mmHg or lower than 90 mmHg,diastolic blood pressure more than 110 mmHg or lower than 60 mmHg.
- •Serious heart,liver,kidney, pulmonary, and endocrine disease or serious infection.
- •Suspected or confirmed difficult airway.
- •History of abnormal anesthesia.
- •Suspected of malignant hyperthermia.
- •Use of sedative and antidepressant drug or serious alcoholism
- •Mini-mental State Examination less than
- •Highest academic degree below grade 6 in primary schools
- •Patients inability to exchange with serious visual and hearing impairment or mental disability.
- •History of shock.
Arms & Interventions
Normal saline
Continuous pump infusion of normal saline with identical volume, compared with the low dose and high dose group,until the end of surgery
Intervention: Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium
Normal saline
Continuous pump infusion of normal saline with identical volume, compared with the low dose and high dose group,until the end of surgery
Intervention: Normal saline
Normal saline
Continuous pump infusion of normal saline with identical volume, compared with the low dose and high dose group,until the end of surgery
Intervention: Maintenance of anesthesia , propofol, remifentanil,vecuronium
High dose group, dexmedetomidine
Continuous pump infusion dexmedetomidine at 1μg/kg for 15 minutes before anesthesia induction ,then continuous pump infusion dexmedetomidine at 0.4μg/kg/h until the end of surgery
Intervention: Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium
High dose group, dexmedetomidine
Continuous pump infusion dexmedetomidine at 1μg/kg for 15 minutes before anesthesia induction ,then continuous pump infusion dexmedetomidine at 0.4μg/kg/h until the end of surgery
Intervention: Dexmedetomidine
High dose group, dexmedetomidine
Continuous pump infusion dexmedetomidine at 1μg/kg for 15 minutes before anesthesia induction ,then continuous pump infusion dexmedetomidine at 0.4μg/kg/h until the end of surgery
Intervention: Maintenance of anesthesia , propofol, remifentanil,vecuronium
Low dose group, dexmedetomidine
Continuous pump infusion dexmedetomidine at 0.5μg/kg for 15 minutes before anesthesia induction ,then continuous pump infusion dexmedetomidine at 0.2μg/kg/h until the end of surgery
Intervention: Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium
Low dose group, dexmedetomidine
Continuous pump infusion dexmedetomidine at 0.5μg/kg for 15 minutes before anesthesia induction ,then continuous pump infusion dexmedetomidine at 0.2μg/kg/h until the end of surgery
Intervention: Dexmedetomidine
Low dose group, dexmedetomidine
Continuous pump infusion dexmedetomidine at 0.5μg/kg for 15 minutes before anesthesia induction ,then continuous pump infusion dexmedetomidine at 0.2μg/kg/h until the end of surgery
Intervention: Maintenance of anesthesia , propofol, remifentanil,vecuronium
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Heart rate(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(At the beginning of operation,at the end of operation,up to 24 hours)
- Total volume of fluid(At the beginning of operation,at the end of operation,up to 24 hours)
- Duration of one lung ventilation(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(At the beginning of surgery,at the end of surgery,up to 24 hours)
- The total dose of analgesic drugs(During perioperative period,up to 7 days)
- Blood pressure(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(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(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(At the beginning of surgery,at the end of surgery,up to 24 hours)