Back to resultsEffects of Dexmedetomidine on Postoperative Cognitive Dysfunction During One-lung Ventilation in Elder Patients
Primary Purpose
Postoperative Confusion
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium
Dexmedetomidine
Normal saline
Maintenance of anesthesia , propofol, remifentanil,vecuronium
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Confusion
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 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 .
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Normal saline
High dose group, dexmedetomidine
Low dose group, dexmedetomidine
Arm Description
Continuous pump infusion of normal saline with identical volume, compared with the low dose and high dose group,until the end of surgery
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
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
Outcomes
Primary Outcome Measures
The change in memory
The change in memory will be evaluated by Controlled Oral Word Association Test ,Semantic Fluency test
Cognitive function
Cognitive function will be evaluated by Mini-mentalStateExamination,Digit-Symbol Substitution Test ,Trail Making Test
Postoperative anxiety
Self-evaluation of Depression Symptoms form,Self-Rating Anxiety Scale,Visual analog scales
Secondary Outcome Measures
Heart rate
Bleeding volume
Total volume of fluid
Duration of one lung ventilation
The total dose of anaesthetic drugs
The total dose of analgesic drugs
Blood pressure
Oxygen saturation
End-tidal carbon dioxide
Operation duration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02134093
Brief Title
Effects of Dexmedetomidine on Postoperative Cognitive Dysfunction During One-lung Ventilation in Elder Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tang-Du Hospital
4. Oversight
5. Study Description
Brief Summary
This study is to explore the effects of dexmedetomidine on postoperative cognitive dysfunction during one-lung ventilation in elder patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Confusion
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Continuous pump infusion of normal saline with identical volume, compared with the low dose and high dose group,until the end of surgery
Arm Title
High dose group, dexmedetomidine
Arm Type
Experimental
Arm Description
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
Arm Title
Low dose group, dexmedetomidine
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium
Intervention Description
Anesthesia induction:midazolam (0.03~0.05 mg/kg), sufentanil(0. 5~0.8 μg/kg), etomidate ( 0.2~0.6mg/kg) and rocuronium(0.6mg/kg)
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Continuous pump infusion dexmedetomidine at 0.5μg/kg （low dose group）or 1μg/kg （high dose group）for 15 minutes before anesthesia induction，then followed by a continuous pump infusion at 0.2 μg/kg/h（low dose group）or 0.4μg/kg/h（high dose group） until the end of surgery.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Continuous pump infusion normal saline with identical volume of dexmedetomidine.
Intervention Type
Drug
Intervention Name(s)
Maintenance of anesthesia , propofol, remifentanil,vecuronium
Intervention Description
Continuous infusion of propofol （3~6 mg/kg/h）, remifentanil （0.05~0.3 μg/kg/min）is required to maintain Entropy within 40~60,Mean Arterial Blood Pressure more than 20% of baseline level , Oxygen Saturation more than 90% , airway pressure less than 40 cm H2O, intermittent injection vecuronium （0.05~0.1mg/kg） as needed to maintain muscle relaxation.
Primary Outcome Measure Information:
Title
The change in memory
Description
The change in memory will be evaluated by Controlled Oral Word Association Test ,Semantic Fluency test
Time Frame
one day before operation, first day after operation
Title
Cognitive function
Description
Cognitive function will be evaluated by Mini-mentalStateExamination,Digit-Symbol Substitution Test ,Trail Making Test
Time Frame
one day before operation, first day after operation
Title
Postoperative anxiety
Description
Self-evaluation of Depression Symptoms form,Self-Rating Anxiety Scale,Visual analog scales
Time Frame
one day before operation, first day after operation
Secondary Outcome Measure Information:
Title
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
Title
Bleeding volume
Time Frame
At the beginning of operation,at the end of operation,up to 24 hours
Title
Total volume of fluid
Time Frame
At the beginning of operation,at the end of operation,up to 24 hours
Title
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
Title
The total dose of anaesthetic drugs
Time Frame
At the beginning of surgery,at the end of surgery,up to 24 hours
Title
The total dose of analgesic drugs
Time Frame
During perioperative period,up to 7 days
Title
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
Title
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
Title
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
Title
Operation duration
Time Frame
At the beginning of surgery,at the end of surgery,up to 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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 .
12. IPD Sharing Statement
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Effects of Dexmedetomidine on Postoperative Cognitive Dysfunction During One-lung Ventilation in Elder Patients
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