Studies of Application of Combined General Anesthesia and Bilateral TPVB in OPCABG
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2016
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedFirst Posted
Study publicly available on registry
April 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedApril 5, 2016
March 1, 2016
5 months
February 22, 2016
March 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Fasting blood glucose
1day before and 4days after operation
baseline and 4 days
Blood Lactic Acid
1day before and 4days after operation
baseline and 4 days
Creatine kinase isoenzymes
1day before and 4days after operation
baseline and 4 days
Myoglobin
1day before and 4days after operation
baseline and 4 days
Troponin I
1day before and 4days after operation
baseline and 4 days
White Blood Cell
1day before and 4days after operation
baseline and 4 days
C-reactive protein
1day before and 4days after operation
baseline and 4 days
N-terminal B-type natriuretic peptide（NT-proBNP)
1day before and 4days after operation
baseline and 4 days
Secondary Outcomes (14)
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
- +9 more secondary outcomes
Other Outcomes (1)
The scores of mini-mental state examination
From the end of surgery, up to 48 hours
Study Arms (3)
TPVB T2/3+T5/6+GA
EXPERIMENTALthe 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
EXPERIMENTALthe 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
PLACEBO COMPARATORgroup C under control (without TPVB)program Device: The use of Transesophageal Echocardiography（TEE）、STAT PROFILE® and Haemonetics® during the surgery
Interventions
group A under TPVB((TPVB T2/3+T5/6) by ropivacaine(0.3%,10ml\*4)program
1. Apply Transesophageal Echocardiography（TEE）after anesthesia induction and draw 400ml autologous blood (Haemonetics®)used for the postoperative transfusion; 2. Goal-directed fluid management
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.
group B under(TPVB T3/4)by ropivacaine(0.3%,20ml\*2)program
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xiangya Hospital of Central South University
Changsha, Hunan, 410078, China
Related Publications (4)
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.
PMID: 17855198BACKGROUNDGanapathy 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.
PMID: 10527232RESULTMehta 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.
PMID: 18603748RESULTDhole 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.
PMID: 11426357RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
e wang, phD
Xiangya Hospital of Central South University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2016
First Posted
April 5, 2016
Study Start
April 1, 2016
Primary Completion
September 1, 2016
Study Completion
December 1, 2016
Last Updated
April 5, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will share