Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Dexmedetomidine on Postoperative Cognitive Dysfunction During One-lung Ventilation in Elder Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02134093
Recruitment Status : Unknown
Verified July 2014 by YangLu, Tang-Du Hospital.
Recruitment status was:  Not yet recruiting
First Posted : May 8, 2014
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
YangLu, 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.

Condition or disease Intervention/treatment Phase
Postoperative Confusion Drug: Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium Drug: Dexmedetomidine Drug: Normal saline Drug: Maintenance of anesthesia , propofol, remifentanil,vecuronium Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : July 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 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
Drug: 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)

Drug: Normal saline
Continuous pump infusion normal saline with identical volume of dexmedetomidine.

Drug: 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.

Experimental: 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
Drug: 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)

Drug: 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.

Drug: 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.

Experimental: 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
Drug: 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)

Drug: 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.

Drug: 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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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 Outcome Measures :
  1. 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 ]
  2. Bleeding volume [ Time Frame: At the beginning of operation,at the end of operation,up to 24 hours ]
  3. Total volume of fluid [ Time Frame: At the beginning of operation,at the end of operation,up to 24 hours ]
  4. 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 ]
  5. The total dose of anaesthetic drugs [ Time Frame: At the beginning of surgery,at the end of surgery,up to 24 hours ]
  6. The total dose of analgesic drugs [ Time Frame: During perioperative period,up to 7 days ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. Operation duration [ Time Frame: At the beginning of surgery,at the end of surgery,up to 24 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 .
Layout table for additonal information
Responsible Party: YangLu, physician, Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT02134093    
Other Study ID Numbers: Tangdu sedation
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Confusion
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Midazolam
Sufentanil
Dexmedetomidine
Remifentanil
Anesthetics
Propofol
Etomidate
Vecuronium Bromide
Rocuronium
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents