Anesthesia
Conditions
Keywords
troponin I, creatine kinase mb, hospital days, lymphocyte apoptosis, intensive care unit days
Brief 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 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.
Interventions
DRUGSevoflurane
anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
DRUGPropofol
anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
DRUGcombine of sevoflurane and propofol
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)
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* male adults * aged 18-80 yr * undergoing elective OPCAB surgery containing left anterior descending artery bypass
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lymphocyte Count | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Intensive Care Unit Staying Days | participants will stay in intensive care unit after surgery, an expected average of 2 days |
Countries
China
Participant flow
Recruitment details
Patient recruitment took place from October 9, 2011 to January 12, 2012 in Ruijin Hospital. A total of 149 patients scheduled to undergo elective OPCABG surgery were assessed for eligibility, with 105 patients enrolled and allocated randomly.
Pre-assignment details
A total of 105 patients enrolled and allocated randomly. Five of these patients were excluded after enrollment (four due to changes in surgical schedules, and one due to severe hemodynamic instability during clamping of the coronary artery and requiring cardiopulmonary bypass).
Participants by arm
| Arm | Count |
|---|---|
| Sevoflurane Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration) | 33 |
| Propofol Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion) | 34 |
| Combine of Sevoflurane and Propofol combine of sevoflurane and propofol: 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) | 33 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 2 | 1 | 2 |
Baseline characteristics
| Characteristic | Sevoflurane | Propofol | Combine of Sevoflurane and Propofol | Total |
|---|---|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 8 | 62 years STANDARD_DEVIATION 8 | 65 years STANDARD_DEVIATION 9 | 63 years STANDARD_DEVIATION 8 |
| Region of Enrollment China | 33 participants | 34 participants | 33 participants | 100 participants |
| Sex: Female, Male Female | 33 Participants | 34 Participants | 33 Participants | 100 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 34 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 34 | 0 / 33 |
Outcome results
Primary
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.
Time frame: 1 day after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sevoflurane | Lymphocyte Count | 0.55 cells/nanoliter | Standard Deviation 0.25 |
| Propofol | Lymphocyte Count | 0.73 cells/nanoliter | Standard Deviation 0.27 |
| Combine of Sevoflurane and Propofol | Lymphocyte Count | 0.73 cells/nanoliter | Standard Deviation 0.31 |
Secondary
Intensive Care Unit Staying Days
Time frame: participants will stay in intensive care unit after surgery, an expected average of 2 days