General Anesthesia, Thoracic Epidural AnesthesiaPhase 4NCT01725607
Postoperative Sleep Quality in Patients Undergoing Thoracic Surgery With Different Types of Anesthesia Management
A Phase 4 study testing general anesthesia combined with dexmedetomidine infusion and general anesthesia combined with TEA in people with General Anesthesia, Thoracic Epidural Anesthesia, run by China Medical University, China at 1 site in China.
Trial summary
We designed a study to determine whether a single dose of dexmedetomidine or thoracic epidural anesthesia combined with general anesthesia would provide hemodynamic stability, reduce stress hormone responses, inhibit inflammatory cytokine secretion, and improve sleep quality in patients after thoracic surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- General Anesthesia, Thoracic Epidural Anesthesia
- What is being tested?
- general anesthesia combined with dexmedetomidine infusion and general anesthesia combined with TEA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Mar 2014
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lung surgery
- one-lung ventilation.
Who cannot join
- body mass index exceeding 30 kg/m2,
- autonomic dysfunction,
- cardiovascular disease,
- neurological or psychiatric diseases
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, the First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
We designed a study to determine whether a single dose of dexmedetomidine or thoracic epidural anesthesia combined with general anesthesia would provide hemodynamic stability, reduce stress hormone responses, inhibit inflammatory cytokine secretion, and improve sleep quality in patients after thoracic surgery.
Read the detailed description
We designed a prospective, single-blinded, randomized, and controlled study to determine whether a single dose of dexmedetomidine or thoracic epidural anesthesia combined with general anesthesia would provide hemodynamic stability, reduce stress hormone responses, inhibit inflammatory cytokine secretion, and improve sleep quality in patients after thoracic surgery.
- Being tested
- general anesthesia combined with dexmedetomidine infusion, general anesthesia combined with TEA
- Keywords
- dexmedetomidine, thoracic epidural anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anesthesia combined with dexmedetomidine infusionDrug
general anesthesia combined with 1 μg/kg dexmedetomidine infusion after induction (Group D)
general anesthesia combined with TEAProcedure or surgery
general anesthesia combined with TEA (Group E)
| Study group | Role | What they receive |
|---|---|---|
| the control group (Group C) | No intervention | general anesthesia |
| general anesthesia combined with dexmedetomidine infusion | Experimental | general anesthesia combined with 1 μg/kg dexmedetomidine infusion after induction (Group D) Receives: Drug: general anesthesia combined with dexmedetomidine infusion |
| general anesthesia combined with TEA | Experimental | general anesthesia combined with TEA (Group E) Receives: Procedure: general anesthesia combined with TEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammatory cytokine secretion and postoperative sleep quality
Primary outcomes were inflammatory cytokine secretion and postoperative sleep quality, which was measured with the BIS data on first and second postoperative nights.
Measured: immediately before anesthesia (T1), 5 min after endotracheal intubation (T2), immediately after incision (T3), 5 min after OLV initiation (T4), 5 min after double-lung ventilation initiation (T5), and immediately after extubation (T6)
Secondary outcomes (1)
amine secretion during the surgical period and hemodynamic stability
amine (epinephrine and norepinephrine) secretion during the surgical period and hemodynamic stability
Measured: immediately before anesthesia (T1), 5 min after endotracheal intubation (T2), immediately after incision (T3), 5 min after OLV initiation (T4), 5 min after double-lung ventilation initiation (T5), and immediately after extubation (T6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anesthesia, Thoracic Epidural AnesthesiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-fei Tan, China Medical University, China
- Investigators
- Hong Ma, M.D.,PhD., Study chair, Dept. of Anesthesiology, the First Hospital of CMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725607
- Sponsor's protocol ID
- 20121101
- Status last verified
- Oct 2013
- First submitted
- 3 Nov 2012
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Sleep Quality in Patients Undergoing Thoracic Surgery With Different Types of Anesthesia Management
- ClinicalTrials.gov ID
- NCT01725607
- Acronym / sponsor ID
- 20121101
- Keywords
- dexmedetomidine, thoracic epidural anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 14 Nov 2012 (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.
We designed a study to determine whether a single dose of dexmedetomidine or thoracic epidural anesthesia combined with general anesthesia would provide hemodynamic stability, reduce stress hormone responses, inhibit inflammatory cytokine secretion, and improve sleep quality in patients after thoracic surgery.
Detailed description
We designed a prospective, single-blinded, randomized, and controlled study to determine whether a single dose of dexmedetomidine or thoracic epidural anesthesia combined with general anesthesia would provide hemodynamic stability, reduce stress hormone responses, inhibit inflammatory cytokine secretion, and improve sleep quality in patients after thoracic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the control group (Group C) | No intervention | –general anesthesia |
| general anesthesia combined with dexmedetomidine infusion | Experimental | Drug: general anesthesia combined with dexmedetomidine infusiongeneral anesthesia combined with 1 μg/kg dexmedetomidine infusion after induction (Group D) |
| general anesthesia combined with TEA | Experimental | Procedure: general anesthesia combined with TEAgeneral anesthesia combined with TEA (Group E) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- lung surgery
- one-lung ventilation.
Key exclusion criteria (4 listed)
- body mass index exceeding 30 kg/m2,
- autonomic dysfunction,
- cardiovascular disease,
- neurological or psychiatric diseases
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 |
|---|---|---|
| general anesthesia combined with dexmedetomidine infusiongeneral anesthesia combined with 1 μg/kg dexmedetomidine infusion after induction (Group D) | Drug | general anesthesia combined with dexmedetomidine infusion |
| general anesthesia combined with TEAgeneral anesthesia combined with TEA (Group E) | Procedure or surgery | general anesthesia combined with TEA |
Primary outcome
inflammatory cytokine secretion and postoperative sleep quality
Time frame: immediately before anesthesia (T1), 5 min after endotracheal intubation (T2), immediately after incision (T3), 5 min after OLV initiation (T4), 5 min after double-lung ventilation initiation (T5), and immediately after extubation (T6)
Primary outcomes were inflammatory cytokine secretion and postoperative sleep quality, which was measured with the BIS data on first and second postoperative nights.
1 secondary outcome
amine secretion during the surgical period and hemodynamic stability
Time frame: immediately before anesthesia (T1), 5 min after endotracheal intubation (T2), immediately after incision (T3), 5 min after OLV initiation (T4), 5 min after double-lung ventilation initiation (T5), and immediately after extubation (T6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
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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.
Hong Ma, M.D.,PhD. study chair
Dept. of Anesthesiology, the First Hospital of CMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing general anesthesia combined with dexmedetomidine infusion and general anesthesia combined with TEA in people with General Anesthesia, Thoracic Epidural Anesthesia, run by China Medical University, China at 1 site in China.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
inflammatory cytokine secretion and postoperative sleep quality (time frame: immediately before anesthesia (T1), 5 min after endotracheal intubation (T2), immediately after incision (T3), 5 min after OLV initiation (T4), 5 min after double-lung ventilation initiation (T5), and immediately after extubation (T6)). 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 8 Jul 2015.