AnesthesiaOPCABNCT01461551
Anesthesia and Lymphocytes Apoptosis
A study testing Sevoflurane, Propofol and combine of sevoflurane and propofol in people with Anesthesia, run by Ruijin Hospital at 1 site in China.
Trial summary
Most researches revealed that volatile anesthetic sevoflurane has a more marked cardioprotective effect against ischemia compared with intravenous agent propofol.However, propofol has been suggested to be more benefit for attenuation of surgery-induced immunosuppression.Thus, the aim of this study was to investigate… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Anesthesia
- What is being tested?
- Sevoflurane, Propofol and combine of sevoflurane and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- Oct 2011to Oct 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male adults
- aged 18-80 yr
- undergoing elective OPCAB surgery containing left anterior descending artery bypass
Who cannot join
- a previous unusual response to any of the experimental anesthetics
- severe cardiac dysrhythmias or ejection fraction below 30%
- hemodynamic instability
- previous surgical coronary artery repair
- anemia, abnormal leukocytes or coagulopathy
- severe hypertension
Show all 9Show fewer
- severe hepatic (albumin<30g,ascites), renal (serum creatinine greater than 2.0 mg/dl) or pulmonary (preoperative pulmonary function tests moderate-severe) dysfunctions
- concomitant surgical procedures and psychiatric disorders
- Insulin-dependent diabetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Different Effects of Sevoflurane, Propofol and Combine of Sevoflurane and Propofol Maintained Anesthesia on Peripheral Blood Lymphocytes During Off-pump Coronary Artery Bypass Graft Surgery
Most researches revealed that volatile anesthetic sevoflurane has a more marked cardioprotective effect against ischemia compared with intravenous agent propofol.However, propofol has been suggested to be more benefit for attenuation of surgery-induced immunosuppression.Thus, the aim of this study was to investigate under the specific OPCAB surgical stress, the influence of 3 established anesthetic techniques: sevoflurane, propofol and combine of sevoflurane and propofol maintained anesthesia on the apoptosis of circulating lymphocytes.
- Conditions
- Anesthesia
- Being tested
- Sevoflurane, Propofol, combine of sevoflurane and propofol
- Keywords
- troponin I, creatine kinase mb, hospital days, lymphocyte apoptosis, intensive care unit days
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
PropofolDrug
anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
combine of sevoflurane and propofolDrug
anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Experimental | Not described Receives: Drug: Sevoflurane |
| Propofol | Experimental | Not described Receives: Drug: Propofol |
| Combine of sevoflurane and propofol | Experimental | Not described Receives: Drug: combine of sevoflurane and propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphocyte Count
Blood samples were obtained 24 h after the surgery for routine blood examination. This analysis was performed in the hospital laboratory using routine laboratory procedures.
Measured: 1 day after surgery
Secondary outcomes (1)
Intensive Care Unit Staying Days
Measured: participants will stay in intensive care unit after surgery, an expected average of 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2012
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ruijin 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Jie Jia, Ruijin Hospital
- Investigators
- Bu-Wei Yu, Ph.D., M.D., Study director, Department of Anesthesiology, Ruijin Hospital, Shanghai Jiao tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461551
- Sponsor's protocol ID
- OPCAB
- Acronym
- OPCAB
- Status last verified
- May 2015
- First submitted
- 19 Oct 2011
- Last updated
- 22 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Jia L, Dong R, Zhang F, Wang W, Lu H, Luo Y, Xue Q, Yu B. Propofol Provides More Effective Protection for Circulating Lymphocytes Than Sevoflurane in Patients Undergoing Off-Pump Coronary Artery Bypass Graft Surgery. J Cardiothorac Vasc Anesth. 2015 Oct;29(5):1172-9. doi: 10.1053/j.jvca.2015.01.008. Epub 2015 Feb 19.
PubMed 26205644
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Effects of Sevoflurane, Propofol and Combine of Sevoflurane and Propofol Maintained Anesthesia on Peripheral Blood Lymphocytes During Off-pump Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT01461551
- Acronym / sponsor ID
- OPCAB / OPCAB
- Conditions
- Anesthesia
- Keywords
- troponin I, creatine kinase mb, hospital days, lymphocyte apoptosis, intensive care unit days
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Oct 2011 (estimated)
- Results
- Posted 20 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most researches revealed that volatile anesthetic sevoflurane has a more marked cardioprotective effect against ischemia compared with intravenous agent propofol.However, propofol has been suggested to be more benefit for attenuation of surgery-induced immunosuppression.Thus, the aim of this study was to investigate under the specific OPCAB surgical stress, the influence of 3 established anesthetic techniques: sevoflurane, propofol and combine of sevoflurane and propofol maintained anesthesia on the apoptosis of circulating lymphocytes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Experimental | Drug: Sevoflurane |
| Propofol | Experimental | Drug: Propofol |
| Combine of sevoflurane and propofol | Experimental | Drug: combine of sevoflurane and propofol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male adults
- aged 18-80 yr
- undergoing elective OPCAB surgery containing left anterior descending artery bypass
Key exclusion criteria (9 listed)
- a previous unusual response to any of the experimental anesthetics
- severe cardiac dysrhythmias or ejection fraction below 30%
- hemodynamic instability
- previous surgical coronary artery repair
- anemia, abnormal leukocytes or coagulopathy
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 |
|---|---|---|
| Sevofluraneanesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration) | Drug | Sevoflurane |
| Propofolanesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion) | Drug | Propofol |
| combine of sevoflurane and propofolanesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration) | Drug | Combine of sevoflurane and propofol |
Primary outcome
Lymphocyte Count
Time frame: 1 day after surgery
Blood samples were obtained 24 h after the surgery for routine blood examination. This analysis was performed in the hospital laboratory using routine laboratory procedures.
1 secondary outcome
Intensive Care Unit Staying Days
Time frame: participants will stay in intensive care unit after surgery, an expected average of 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26205644Jia L, Dong R, Zhang F, Wang W, Lu H, Luo Y, Xue Q, Yu B. Propofol Provides More Effective Protection for Circulating Lymphocytes Than Sevoflurane in Patients Undergoing Off-Pump Coronary Artery Bypass Graft Surgery. J Cardiothorac Vasc Anesth. 2015 Oct;29(5):1172-9. doi: 10.1053/j.jvca.2015.01.008. Epub 2015 Feb 19.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Related trials for Anesthesia
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
Active, not recruitingObservational study
Dexmedetomidine Nasal Spray and Postoperative Sore Throat After Bronchoscopy
Postoperative Sore Throat, Bronchoscopy
Recruiting
Buzzy Bee for Pain and Anxiety Control During Pediatric Dental Local Anesthesia
Anesthesia, Anxiety
Recruiting
Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
Paroxysmal Atrial Fibrillation
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.
Bu-Wei Yu, Ph.D., M.D. study director
Department of Anesthesiology, Ruijin Hospital, Shanghai Jiao tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane, Propofol and combine of sevoflurane and propofol in people with Anesthesia, run by Ruijin Hospital 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 3 inclusion and 9 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 22 May 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lymphocyte Count (time frame: 1 day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01461551, which also lists 1 linked publication.
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 22 May 2015.