Effects of Dexmedetomidine on Postoperative Cognitive Dysfunction During One-lung Ventilation in Elder Patients
Phase 4
- Conditions
- Postoperative Confusion
- Interventions
- Drug: Normal salineDrug: Maintenance of anesthesia , propofol, remifentanil,vecuronium
- Registration Number
- NCT02134093
- Lead Sponsor
- Tang-Du Hospital
- Brief Summary
This study is to explore the effects of dexmedetomidine on postoperative cognitive dysfunction during one-lung ventilation in elder patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
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 17.
- 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.
- Carotid artery stenosis and central nervous system disease such as stroke, epilepsy.
- Allergic to investigational products or with other contraindication.
- Participated in other study within 30 days .
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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 High dose group, dexmedetomidine Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium 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 High dose group, dexmedetomidine Maintenance of anesthesia , propofol, remifentanil,vecuronium 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 Low dose group, dexmedetomidine Maintenance of anesthesia , propofol, remifentanil,vecuronium 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 Normal saline Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium Continuous pump infusion of normal saline with identical volume, compared with the low dose and high dose group,until the end of surgery Normal saline Maintenance of anesthesia , propofol, remifentanil,vecuronium Continuous pump infusion of normal saline with identical volume, compared with the low dose and high dose group,until the end of surgery Low dose group, dexmedetomidine Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium 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 High dose group, dexmedetomidine 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 Low dose group, dexmedetomidine 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
- Primary Outcome Measures
Name Time Method The change in memory 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 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 one day before operation, first day after operation Self-evaluation of Depression Symptoms form,Self-Rating Anxiety Scale,Visual analog scales
- Secondary Outcome Measures
Name Time Method 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