Clinical trial NCT02134093: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Confusion
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2014-05-08
Enrollment: 120
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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 .

Primary outcomes:
measure: The change in memory
timeFrame: one day before operation, first day after operation
measure: Cognitive function
timeFrame: one day before operation, first day after operation
measure: Postoperative anxiety
timeFrame: one day before operation, first day after operation
Secondary outcomes:
measure: Heart rate
timeFrame: 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
measure: Bleeding volume
timeFrame: At the beginning of operation,at the end of operation,up to 24 hours
measure: Total volume of fluid
timeFrame: At the beginning of operation,at the end of operation,up to 24 hours
measure: Duration of one lung ventilation
timeFrame: At the beginning of one lung ventilation,at the end of one lung ventilation,an expected average of 3 hours
measure: The total dose of anaesthetic drugs
timeFrame: At the beginning of surgery,at the end of surgery,up to 24 hours
measure: The total dose of analgesic drugs
timeFrame: During perioperative period,up to 7 days
measure: Blood pressure
timeFrame: 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
measure: Oxygen saturation
timeFrame: 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
measure: End-tidal carbon dioxide
timeFrame: 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
measure: Operation duration
timeFrame: At the beginning of surgery,at the end of surgery,up to 24 hours
Other outcomes:
Locations:
Study officials:
References: