Postoperative ConfusionPhase 4NCT02134093
Effects of Dexmedetomidine on Postoperative Cognitive Dysfunction During One-lung Ventilation in Elder Patients
A Phase 4 study testing Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium, Dexmedetomidine and Normal saline in people with Postoperative Confusion, run by Tang-Du Hospital.
Trial summary
This study is to explore the effects of dexmedetomidine on postoperative cognitive dysfunction during one-lung ventilation in elder patients. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Postoperative Confusion
- What is being tested?
- Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium, Dexmedetomidine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 .
About this study
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
This study is to explore the effects of dexmedetomidine on postoperative cognitive dysfunction during one-lung ventilation in elder patients.
- Conditions
- Postoperative Confusion
- Being tested
- Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium, Dexmedetomidine, Normal saline, Maintenance of anesthesia , propofol, remifentanil,vecuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuroniumDrug
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)
DexmedetomidineDrug
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 salineDrug
Continuous pump infusion normal saline with identical volume of dexmedetomidine.
Maintenance of anesthesia , propofol, remifentanil,vecuroniumDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal saline | Placebo comparator | Continuous pump infusion of normal saline with identical volume, compared with the low dose and high dose group,until the end of surgery Receives: Drug: Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium; Drug: Normal saline; Drug: Maintenance of anesthesia , propofol, remifentanil,vecuronium |
| High dose group, dexmedetomidine | Experimental | 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 Receives: Drug: Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium; Drug: Dexmedetomidine; Drug: Maintenance of anesthesia , propofol, remifentanil,vecuronium |
| Low dose group, dexmedetomidine | Experimental | 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 Receives: Drug: Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium; Drug: Dexmedetomidine; Drug: Maintenance of anesthesia , propofol, remifentanil,vecuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in memory
The change in memory will be evaluated by Controlled Oral Word Association Test ,Semantic Fluency test
Measured: one day before operation, first day after operation
Cognitive function
Cognitive function will be evaluated by Mini-mentalStateExamination,Digit-Symbol Substitution Test ,Trail Making Test
Measured: one day before operation, first day after operation
Postoperative anxiety
Self-evaluation of Depression Symptoms form,Self-Rating Anxiety Scale,Visual analog scales
Measured: one day before operation, first day after operation
Secondary outcomes (10)
Heart rate
Measured: 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
Measured: At the beginning of operation,at the end of operation,up to 24 hours
Total volume of fluid
Measured: At the beginning of operation,at the end of operation,up to 24 hours
Duration of one lung ventilation
Measured: 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
Measured: At the beginning of surgery,at the end of surgery,up to 24 hours
The total dose of analgesic drugs
Measured: During perioperative period,up to 7 days
Blood pressure
Measured: 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
Measured: 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
Measured: 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
Measured: At the beginning of surgery,at the end of surgery,up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ConfusionStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YangLu, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134093
- Sponsor's protocol ID
- Tangdu sedation
- Status last verified
- Jul 2014
- First submitted
- 29 Apr 2014
- Last updated
- 11 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02134093
- Acronym / sponsor ID
- Tangdu sedation
- Conditions
- Postoperative Confusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 8 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to explore the effects of dexmedetomidine on postoperative cognitive dysfunction during one-lung ventilation in elder patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal saline | Placebo comparator | Drug: Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium, Drug: Normal saline, Drug: Maintenance of anesthesia , propofol, remifentanil,vecuroniumContinuous pump infusion of normal saline with identical volume, compared with the low dose and high dose group,until the end of surgery |
| High dose group, dexmedetomidine | Experimental | Drug: Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium, Drug: Dexmedetomidine, Drug: Maintenance of anesthesia , propofol, remifentanil,vecuroniumContinuous 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 |
| Low dose group, dexmedetomidine | Experimental | Drug: Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium, Drug: Dexmedetomidine, Drug: Maintenance of anesthesia , propofol, remifentanil,vecuroniumContinuous 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 |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuroniumAnesthesia 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 | High dose group, dexmedetomidine, Low dose group, dexmedetomidine, Normal saline |
| DexmedetomidineContinuous 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 | High dose group, dexmedetomidine, Low dose group, dexmedetomidine |
| Normal salineContinuous pump infusion normal saline with identical volume of dexmedetomidine. | Drug | Normal saline |
| Maintenance of anesthesia , propofol, remifentanil,vecuroniumContinuous 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 | High dose group, dexmedetomidine, Low dose group, dexmedetomidine, Normal saline |
Primary outcome
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
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
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
10 secondary outcomes
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
Bleeding volume
Time frame: 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
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
The total dose of anaesthetic drugs
Time frame: 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
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
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
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
Operation duration
Time frame: At the beginning of surgery,at the end of surgery,up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium, Dexmedetomidine and Normal saline in people with Postoperative Confusion, run by Tang-Du Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in memory (time frame: one day before operation, first day after operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2014.