Studies of Application of Combined General Anesthesia and Bilateral TPVB in OPCABG
NCT ID: NCT02727712
Last Updated: 2016-04-05
Study Results
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Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2016-04-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
bilateral thoracic paravertebral block
group A under TPVB((TPVB T2/3+T5/6) by ropivacaine(0.3%,10ml\*4)program
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
Lung protection measure during the surgery（Dräger Primus）
Protective ventilation strategy(Low tidal volume about 6\~7ml/kg, joint use of PEEP)
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.
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
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
Lung protection measure during the surgery（Dräger Primus）
Protective ventilation strategy(Low tidal volume about 6\~7ml/kg, joint use of PEEP)
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.
thoracic paravertebral block
group B under(TPVB T3/4)by ropivacaine(0.3%,20ml\*2)program
GA
group C under control (without TPVB)program Device: The use of Transesophageal Echocardiography（TEE）、STAT PROFILE® and Haemonetics® during the surgery
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
Lung protection measure during the surgery（Dräger Primus）
Protective ventilation strategy(Low tidal volume about 6\~7ml/kg, joint use of PEEP)
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.
Interventions
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bilateral thoracic paravertebral block
group A under TPVB((TPVB T2/3+T5/6) by ropivacaine(0.3%,10ml\*4)program
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
Lung protection measure during the surgery（Dräger Primus）
Protective ventilation strategy(Low tidal volume about 6\~7ml/kg, joint use of PEEP)
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.
thoracic paravertebral block
group B under(TPVB T3/4)by ropivacaine(0.3%,20ml\*2)program
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
35 Years
80 Years
ALL
No
Sponsors
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Xiangya Hospital of Central South University
OTHER
Responsible Party
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Principal Investigators
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e wang, phD
Role: PRINCIPAL_INVESTIGATOR
Xiangya Hospital of Central South University
Locations
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Xiangya Hospital of Central South University
Changsha, Hunan, China
Countries
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Central Contacts
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References
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Olivier JF, Bracco D, Nguyen P, Le N, Noiseux N, Hemmerling T; Perioperative Cardiac Surgery Research Group (PeriCARG). A novel approach for pain management in cardiac surgery via median sternotomy: bilateral single-shot paravertebral blocks. Heart Surg Forum. 2007;10(5):E357-62. doi: 10.1532/HSF98.20071082.
Ganapathy S, Murkin JM, Boyd DW, Dobkowski W, Morgan J. Continuous percutaneous paravertebral block for minimally invasive cardiac surgery. J Cardiothorac Vasc Anesth. 1999 Oct;13(5):594-6. doi: 10.1016/s1053-0770(99)90015-0. No abstract available.
Mehta Y, Arora D, Sharma KK, Mishra Y, Wasir H, Trehan N. Comparison of continuous thoracic epidural and paravertebral block for postoperative analgesia after robotic-assisted coronary artery bypass surgery. Ann Card Anaesth. 2008 Jul-Dec;11(2):91-6. doi: 10.4103/0971-9784.41576.
Dhole S, Mehta Y, Saxena H, Juneja R, Trehan N. Comparison of continuous thoracic epidural and paravertebral blocks for postoperative analgesia after minimally invasive direct coronary artery bypass surgery. J Cardiothorac Vasc Anesth. 2001 Jun;15(3):288-92. doi: 10.1053/jcan.2001.23271.
Other Identifiers
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20160131
Identifier Type: -
Identifier Source: org_study_id
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