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

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ClinicalTrials.gov Identifier: NCT02727712
Recruitment Status : Unknown
Verified March 2016 by Xiangya Hospital of Central South University.
Recruitment status was:  Not yet recruiting
First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Procedure: bilateral thoracic paravertebral block Device: Transesophageal Echocardiography(TEE) Device: Lung protection measure during the surgery(Dräger Primus) Drug: Anesthesia drugs during the surgery Procedure: thoracic paravertebral block Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: 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
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.

Experimental: 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
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

Placebo Comparator: GA
group C under control (without TPVB)program Device: The use of Transesophageal Echocardiography(TEE)、STAT PROFILE® and Haemonetics® during the surgery
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.




Primary Outcome Measures :
  1. Fasting blood glucose [ Time Frame: baseline and 4 days ]
    1day before and 4days after operation

  2. Blood Lactic Acid [ Time Frame: baseline and 4 days ]
    1day before and 4days after operation

  3. Creatine kinase isoenzymes [ Time Frame: baseline and 4 days ]
    1day before and 4days after operation

  4. Myoglobin [ Time Frame: baseline and 4 days ]
    1day before and 4days after operation

  5. Troponin I [ Time Frame: baseline and 4 days ]
    1day before and 4days after operation

  6. White Blood Cell [ Time Frame: baseline and 4 days ]
    1day before and 4days after operation

  7. C-reactive protein [ Time Frame: baseline and 4 days ]
    1day before and 4days after operation

  8. N-terminal B-type natriuretic peptide(NT-proBNP) [ Time Frame: baseline and 4 days ]
    1day before and 4days after operation


Secondary Outcome Measures :
  1. Perioperative major adverse events [ Time Frame: From pre-surgery to discharge, up to 4 weeks ]
  2. Perioperative use of vasoactive drug species [ Time Frame: From pre-surgery to discharge, up to 4 weeks ]
  3. Vasoactive drugs Support Hours [ Time Frame: From the start of drugs to stop them, up to 4 weeks ]
  4. Time after deactivation of vasoactive drugs [ Time Frame: From the end of surgery to the deactivation of vasoactive drugs, up to 4 weeks ]
  5. Postoperative tracheal tube time [ Time Frame: From the end of surgery to the removal of tracheal tube, up to 4 weeks ]
  6. Duration of mechanical ventilation after surgery [ Time Frame: From the end of surgery to the recovery of spontaneous breathing, up to 4 weeks ]
  7. The time after the ICU until discharge [ Time Frame: From leaving the ICU to discharge from hospital, up to 4 weeks ]
  8. Length of ICU stay [ Time Frame: From ICU admission to discharge from ICU, up to 4 weeks ]
  9. Recovery time [ Time Frame: From the end of surgery to recover, up to 4 weeks ]
  10. Time to first bowel movement [ Time Frame: From the end of surgery to first bowel movement, up to 2 weeks ]
  11. Postoperative to normal eating time [ Time Frame: From the end of surgery to normal eating, up to 2 weeks ]
  12. The total length of hospital stay [ Time Frame: From admission to discharge, up to 5 weeks ]
  13. Visual analog pain score [ Time Frame: From the end of surgery, up to 48 hours ]
  14. Ramsay score [ Time Frame: From the end of surgery, up to 48 hours ]

Other Outcome Measures:
  1. The scores of mini-mental state examination [ Time Frame: From the end of surgery, up to 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727712


Contacts
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Contact: e Wang, phD +86 731 84327413 ewang324@hotmail.com
Contact: junjie Zhang, MD +86 731 84327411 proforol2199@163.com

Locations
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China, Hunan
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410078
Sponsors and Collaborators
Xiangya Hospital of Central South University
Investigators
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Principal Investigator: e wang, phD Xiangya Hospital of Central South University

Publications of Results:
Other Publications:
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Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT02727712     History of Changes
Other Study ID Numbers: 20160131
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Xiangya Hospital of Central South University:
coronary artery bypass graft
thoracic paravertebral block
Additional relevant MeSH terms:
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Heart Diseases
Ropivacaine
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents