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

July 9, 2014 updated by: YangLu, Tang-Du Hospital

Effects of Dexmedetomidine on Postoperative Cognitive Dysfunction During One-lung Ventilation in Elder Patients -a Single-center, Randomized ,Double-blinded and Controlled Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: 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.
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.
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: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
one day before operation, first day after operation
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
one day before operation, first day after operation
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
one day before operation, first day after operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
Time Frame: At the beginning of operation,at the end of operation,up to 24 hours
At the beginning of operation,at the end of operation,up to 24 hours
Total volume of fluid
Time Frame: At the beginning of operation,at the end of operation,up to 24 hours
At the beginning of operation,at the end of operation,up to 24 hours
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
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
Time Frame: At the beginning of surgery,at the end of surgery,up to 24 hours
At the beginning of surgery,at the end of surgery,up to 24 hours
The total dose of analgesic drugs
Time Frame: During perioperative period,up to 7 days
During perioperative period,up to 7 days
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
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
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
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
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
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
Time Frame: At the beginning of surgery,at the end of surgery,up to 24 hours
At the beginning of surgery,at the end of surgery,up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tang-Du Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Tangdu sedation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings