Studies of Application of Combined General Anesthesia and Bilateral Thoracic Paravertebral Block by Ropivacaine in Patients Undergoing Off-pump Coronary Artery Bridge Graft - a Random Double Blind Controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fasting blood glucose
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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.
研究组 & 干预措施
TPVB T2/3+T5/6+GA
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
干预措施: bilateral thoracic paravertebral block (Procedure)
TPVB T2/3+T5/6+GA
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
干预措施: Transesophageal Echocardiography（TEE） (Device)
TPVB T2/3+T5/6+GA
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
干预措施: Lung protection measure during the surgery（Dräger Primus） (Device)
TPVB T2/3+T5/6+GA
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
干预措施: Anesthesia drugs during the surgery (Drug)
TPVB T3/4+GA
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
干预措施: Transesophageal Echocardiography（TEE） (Device)
TPVB T3/4+GA
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
干预措施: Lung protection measure during the surgery（Dräger Primus） (Device)
TPVB T3/4+GA
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
干预措施: Anesthesia drugs during the surgery (Drug)
TPVB T3/4+GA
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
干预措施: thoracic paravertebral block (Procedure)
GA
group C under control (without TPVB)program Device: The use of Transesophageal Echocardiography（TEE）、STAT PROFILE® and Haemonetics® during the surgery
干预措施: Transesophageal Echocardiography（TEE） (Device)
GA
group C under control (without TPVB)program Device: The use of Transesophageal Echocardiography（TEE）、STAT PROFILE® and Haemonetics® during the surgery
干预措施: Lung protection measure during the surgery（Dräger Primus） (Device)
GA
group C under control (without TPVB)program Device: The use of Transesophageal Echocardiography（TEE）、STAT PROFILE® and Haemonetics® during the surgery
干预措施: Anesthesia drugs during the surgery (Drug)
结局指标
主要结局
Fasting blood glucose
时间窗: baseline and 4 days
1day before and 4days after operation
Blood Lactic Acid
时间窗: baseline and 4 days
1day before and 4days after operation
Creatine kinase isoenzymes
时间窗: baseline and 4 days
1day before and 4days after operation
Myoglobin
时间窗: baseline and 4 days
1day before and 4days after operation
Troponin I
时间窗: baseline and 4 days
1day before and 4days after operation
White Blood Cell
时间窗: baseline and 4 days
1day before and 4days after operation
C-reactive protein
时间窗: baseline and 4 days
1day before and 4days after operation
N-terminal B-type natriuretic peptide（NT-proBNP)
时间窗: baseline and 4 days
1day before and 4days after operation
次要结局
- 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)