Effects of Dexmedetomidine on Postoperative Cognitive Dysfunction During One-lung Ventilation in Elder Patients
NCT ID: NCT02134093
Last Updated: 2014-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2014-07-31
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Postoperative Dexmedetomidine in Prevention of Postoperative Delirium
NCT06382961
Effects of Different Doses of Dexmedetomidine on Postoperative Cognitive Dysfunction in Elderly Hypertensive Patients
NCT02224443
Whether Dexmedetomidine Can Improve the Prognosis of Elderly Patients With Postoperative Cognitive Dysfunction
NCT02923128
Dexmedetomidine and Outcomes of Elderly Admitted to ICU After Surgery
NCT04204798
Impact of Dexmedetomidine on the Post-Operative Cognition Dysfunction(POCD) in Geriatric Patients
NCT02275182
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium
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)
Normal saline
Continuous pump infusion normal saline with identical volume of dexmedetomidine.
Maintenance of anesthesia , propofol, remifentanil,vecuronium
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.
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
Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium
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)
Dexmedetomidine
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.
Maintenance of anesthesia , propofol, remifentanil,vecuronium
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.
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
Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium
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)
Dexmedetomidine
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.
Maintenance of anesthesia , propofol, remifentanil,vecuronium
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium
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)
Dexmedetomidine
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.
Normal saline
Continuous pump infusion normal saline with identical volume of dexmedetomidine.
Maintenance of anesthesia , propofol, remifentanil,vecuronium
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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 .
55 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tang-Du Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
YangLu
physician
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Tangdu sedation
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.