Studies of Application of Combined General Anesthesia and Bilateral TPVB in OPCABG
- Conditions
- Coronary Heart Disease
- Interventions
- Device: Transesophageal Echocardiography（TEE）Procedure: bilateral thoracic paravertebral blockDevice: Lung protection measure during the surgery（Dräger Primus）Drug: Anesthesia drugs during the surgeryProcedure: thoracic paravertebral block
- Registration Number
- NCT02727712
- Lead Sponsor
- Xiangya Hospital of Central South University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TPVB T2/3+T5/6+GA Anesthesia drugs during the surgery the group A of patients has been received bilateral thoracic paravertebral block (TPVB T2/3+T5/6) by ropivacaine(0.3%,10ml\*4), before general anesthesia management TPVB T2/3+T5/6+GA Lung protection measure during the surgery（Dräger Primus） the group A of patients has been received bilateral thoracic paravertebral block (TPVB T2/3+T5/6) by ropivacaine(0.3%,10ml\*4), before general anesthesia management TPVB T3/4+GA Transesophageal Echocardiography（TEE） the group Bof patients has been received bilateral thoracic paravertebral block (TPVB 3/4) by ropivacaine(0.3%,10ml\*4), before general anesthesia management Device: The use of Transesophageal Echocardiography（TEE）、STAT PROFILE® and Haemonetics® during the surgery GA Lung protection measure during the surgery（Dräger Primus） group C under control (without TPVB)program Device: The use of Transesophageal Echocardiography（TEE）、STAT PROFILE® and Haemonetics® during the surgery TPVB T3/4+GA Anesthesia drugs during the surgery the group Bof patients has been received bilateral thoracic paravertebral block (TPVB 3/4) by ropivacaine(0.3%,10ml\*4), before general anesthesia management Device: The use of Transesophageal Echocardiography（TEE）、STAT PROFILE® and Haemonetics® during the surgery TPVB T3/4+GA thoracic paravertebral block the group Bof patients has been received bilateral thoracic paravertebral block (TPVB 3/4) by ropivacaine(0.3%,10ml\*4), before general anesthesia management Device: The use of Transesophageal Echocardiography（TEE）、STAT PROFILE® and Haemonetics® during the surgery GA Transesophageal Echocardiography（TEE） group C under control (without TPVB)program Device: The use of Transesophageal Echocardiography（TEE）、STAT PROFILE® and Haemonetics® during the surgery GA Anesthesia drugs during the surgery group C under control (without TPVB)program Device: The use of Transesophageal Echocardiography（TEE）、STAT PROFILE® and Haemonetics® during the surgery TPVB T2/3+T5/6+GA bilateral thoracic paravertebral block the group A of patients has been received bilateral thoracic paravertebral block (TPVB T2/3+T5/6) by ropivacaine(0.3%,10ml\*4), before general anesthesia management TPVB T3/4+GA Lung protection measure during the surgery（Dräger Primus） the group Bof patients has been received bilateral thoracic paravertebral block (TPVB 3/4) by ropivacaine(0.3%,10ml\*4), before general anesthesia management Device: The use of Transesophageal Echocardiography（TEE）、STAT PROFILE® and Haemonetics® during the surgery TPVB T2/3+T5/6+GA Transesophageal Echocardiography（TEE） the group A of patients has been received bilateral thoracic paravertebral block (TPVB T2/3+T5/6) by ropivacaine(0.3%,10ml\*4), before general anesthesia management
- Primary Outcome Measures
Name Time Method 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
N-terminal B-type natriuretic peptide（NT-proBNP) baseline and 4 days 1day before and 4days after operation
- Secondary Outcome Measures
Name Time Method 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 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 Postoperative to normal eating time From the end of surgery to normal eating, 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
Trial Locations
- Locations (1)
Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China