Coronary Heart Disease
Conditions
Keywords
coronary artery bypass graft, thoracic paravertebral block
Brief summary
This study intends to compare the combination of general anesthesia (GA) and single-shot bilateral thoracic paravertebral block (TPVB) by ropivacaine in the patients undergoing off-pump coronary artery bypass surgery ( OPCAB) with traditional general anesthesia (GA) perioperative management of patients, committed to reducing patient's physical and psychological stress by surgical trauma, achieve the purpose of fast recovery, in order to establish an more effective perioperative management during off-pump coronary artery bypass surgery, improve patients' satisfaction and to accelerate postoperative rehabilitation safely.
Detailed description
This study intends to compare the combination of general anesthesia (GA) and single-shot bilateral thoracic paravertebral block (TPVB) by ropivacaine in the patients undergoing off-pump coronary artery bypass surgery ( OPCAB) with traditional general anesthesia (GA) perioperative management of patients, committed to reducing patient's physical and psychological stress by surgical trauma, achieve the purpose of fast recovery, in order to establish an more effective perioperative management during off-pump coronary artery bypass surgery, improve patients' satisfaction and to accelerate postoperative rehabilitation safely. Patients included in the study (approximately 60 cases) will be randomly divided into PVB(T2/3+T5/6)+GA experimental group (A), PVB(T3/4)+GA experimental group (B)the conventional GA control group (C). All groups received the preoperative preparation, anesthesia and postoperative treatment according to the traditional manner, the group A of patients has been received bilateral thoracic paravertebral block (TPVB T2/3+T5/6) by ropivacaine(0.3%,10ml\*4), group B will received bilateral thoracic paravertebral block (TPVB T3/4)by ropivacaine(0.3%,20ml\*2).,while the group C will received the conventional general anesthesia management without block.
Interventions
group A under TPVB((TPVB T2/3+T5/6) by ropivacaine(0.3%,10ml\*4)program
DEVICETransesophageal Echocardiography（TEE）
1. Apply Transesophageal Echocardiography（TEE）after anesthesia induction and draw 400ml autologous blood (Haemonetics®)used for the postoperative transfusion; 2. Goal-directed fluid management
DEVICELung protection measure during the surgery（Dräger Primus）
Protective ventilation strategy(Low tidal volume about 6\ 7ml/kg, joint use of PEEP)
1. Bilateral thoracic paravertebral block before induction of anesthesia; 2. Fast channel anesthesia • Induction use Sufentanil 0.5\ 1ug/kg, Vecuronium for Injection 0.15mg/kg and Etomidate 0.2\ 0.6mg/kg; ②. Maintain use Sufentanil Hydrochloride for Injection 0.01\ 0.04ug/kg•min, Sevoflurane 0.5\ 1.5MAC（minimum alveolar concentration） and Infusing Dexmedetomidine which load dose 0.5μg/kg in 10min then changed into 0.5-1.0μg/kg•h,Vecuronium 0.06\ 0.12mg/kg•h; ③. Intravenous hydromorphone Hydrochloride Injection 0.15mg/kg before surgery over.
PROCEDUREthoracic paravertebral block
group B under(TPVB T3/4)by ropivacaine(0.3%,20ml\*2)program
Sponsors
Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Heart function grade II - III (Using the cardiac function classification method formulated by American Heart Disease Institute) * The in - hospital was treated with off pump coronary artery bypass grafting（CABG) operation and general anesthesia. * Had a good cognition, and signed the informed consent. * Aged between 35 and 80. * The age, clinical examination and other generally situation of the two groups of patients had no statistical significance. no merger of valvular disease left ventricular ejection fraction \> 40%, do not need intraaortic balloon counterpulsation support, without spinal deformity, no vertebral side clearance space-occupying lesions
Exclusion criteria
* Combined with other blood coagulation dysfunction, serious brain, liver and kidney dysfunction, endocrine system diseases and serious infectious disease. * Patients with severe mental disorders cannot cooperate with the treatment. * Emergency operation * Have taboo of Echocardiography and pulmonary catheterization by echocardiography. * Allergic to Local anesthetics drug. * Suspected or had alcohol, drug abuse history. * Spinal or paravertebral lesions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| N-terminal B-type natriuretic peptide（NT-proBNP) | baseline and 4 days | 1day before and 4days after operation |
| Fasting blood glucose | baseline and 4 days | 1day before and 4days after operation |
| Blood Lactic Acid | baseline and 4 days | 1day before and 4days after operation |
| Creatine kinase isoenzymes | baseline and 4 days | 1day before and 4days after operation |
| Myoglobin | baseline and 4 days | 1day before and 4days after operation |
| Troponin I | baseline and 4 days | 1day before and 4days after operation |
| White Blood Cell | baseline and 4 days | 1day before and 4days after operation |
| C-reactive protein | baseline and 4 days | 1day before and 4days after operation |
Secondary
| Measure | Time frame |
|---|---|
| Length of ICU stay | From ICU admission to discharge from ICU, up to 4 weeks |
| Recovery time | From the end of surgery to recover, up to 4 weeks |
| Time to first bowel movement | From the end of surgery to first bowel movement, up to 2 weeks |
| The total length of hospital stay | From admission to discharge, up to 5 weeks |
| Visual analog pain score | From the end of surgery, up to 48 hours |
| Ramsay score | From the end of surgery, up to 48 hours |
| Postoperative to normal eating time | From the end of surgery to normal eating, up to 2 weeks |
| Perioperative major adverse events | From pre-surgery to discharge, up to 4 weeks |
| Perioperative use of vasoactive drug species | From pre-surgery to discharge, up to 4 weeks |
| Vasoactive drugs Support Hours | From the start of drugs to stop them, up to 4 weeks |
| Time after deactivation of vasoactive drugs | From the end of surgery to the deactivation of vasoactive drugs, up to 4 weeks |
| Postoperative tracheal tube time | From the end of surgery to the removal of tracheal tube, up to 4 weeks |
| Duration of mechanical ventilation after surgery | From the end of surgery to the recovery of spontaneous breathing, up to 4 weeks |
| The time after the ICU until discharge | From leaving the ICU to discharge from hospital, up to 4 weeks |
Other
| Measure | Time frame |
|---|---|
| The scores of mini-mental state examination | From the end of surgery, up to 48 hours |
Countries
China
Contacts
Primary Contacte Wang, phD
Backup Contactjunjie Zhang, MD
Outcome results
None listed