NCT02727712

Studies of Application of Combined General Anesthesia and Bilateral TPVB in OPCABG

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
PROCEDURE	bilateral thoracic paravertebral block	group A under TPVB((TPVB T2/3+T5/6) by ropivacaine(0.3%,10ml\*4)program
DEVICE	Transesophageal 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
DEVICE	Lung protection measure during the surgery（Dräger Primus）	Protective ventilation strategy(Low tidal volume about 6\~7ml/kg, joint use of PEEP)
DRUG	Anesthesia drugs during the surgery	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.
PROCEDURE	thoracic paravertebral block	group B under(TPVB T3/4)by ropivacaine(0.3%,20ml\*2)program

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-09-01
• Completion: 2016-12-01
• First posted: 2016-04-05
• Last updated: 2016-04-05

Locations

1 site across 1 country: China