search
Back to results

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

Primary Purpose

Coronary Heart Disease

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
bilateral thoracic paravertebral block
Transesophageal Echocardiography（TEE）
Lung protection measure during the surgery（Dräger Primus）
Anesthesia drugs during the surgery
thoracic paravertebral block
Sponsored by
Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring coronary artery bypass graft, thoracic paravertebral block

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xiangya Hospital of Central South University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

TPVB T2/3+T5/6+GA

TPVB T3/4+GA

GA

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Fasting blood glucose
1day before and 4days after operation
Blood Lactic Acid
1day before and 4days after operation
Creatine kinase isoenzymes
1day before and 4days after operation
Myoglobin
1day before and 4days after operation
Troponin I
1day before and 4days after operation
White Blood Cell
1day before and 4days after operation
C-reactive protein
1day before and 4days after operation
N-terminal B-type natriuretic peptide（NT-proBNP)
1day before and 4days after operation

Secondary Outcome Measures

Perioperative major adverse events
Perioperative use of vasoactive drug species
Vasoactive drugs Support Hours
Time after deactivation of vasoactive drugs
Postoperative tracheal tube time
Duration of mechanical ventilation after surgery
The time after the ICU until discharge
Length of ICU stay
Recovery time
Time to first bowel movement
Postoperative to normal eating time
The total length of hospital stay
Visual analog pain score
Ramsay score

Full Information

First Posted
February 22, 2016
Last Updated
March 29, 2016
Sponsor
Xiangya Hospital of Central South University
search

1. Study Identification

Unique Protocol Identification Number
NCT02727712
Brief Title
Studies of Application of Combined General Anesthesia and Bilateral TPVB in OPCABG
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 Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
coronary artery bypass graft, thoracic paravertebral block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TPVB T2/3+T5/6+GA
Arm Type
Experimental
Arm Description
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
Arm Title
TPVB T3/4+GA
Arm Type
Experimental
Arm Description
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
Arm Title
GA
Arm Type
Placebo Comparator
Arm Description
group C under control (without TPVB)program Device: The use of Transesophageal Echocardiography（TEE）、STAT PROFILE® and Haemonetics® during the surgery
Intervention Type
Procedure
Intervention Name(s)
bilateral thoracic paravertebral block
Intervention Description
group A under TPVB((TPVB T2/3+T5/6) by ropivacaine(0.3%,10ml*4)program
Intervention Type
Device
Intervention Name(s)
Transesophageal Echocardiography（TEE）
Intervention Description
Apply Transesophageal Echocardiography（TEE）after anesthesia induction and draw 400ml autologous blood (Haemonetics®)used for the postoperative transfusion; Goal-directed fluid management
Intervention Type
Device
Intervention Name(s)
Lung protection measure during the surgery（Dräger Primus）
Intervention Description
Protective ventilation strategy(Low tidal volume about 6~7ml/kg, joint use of PEEP)
Intervention Type
Drug
Intervention Name(s)
Anesthesia drugs during the surgery
Intervention Description
Bilateral thoracic paravertebral block before induction of anesthesia; 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.
Intervention Type
Procedure
Intervention Name(s)
thoracic paravertebral block
Intervention Description
group B under(TPVB T3/4)by ropivacaine(0.3%,20ml*2)program
Primary Outcome Measure Information:
Title
Fasting blood glucose
Description
1day before and 4days after operation
Time Frame
baseline and 4 days
Title
Blood Lactic Acid
Description
1day before and 4days after operation
Time Frame
baseline and 4 days
Title
Creatine kinase isoenzymes
Description
1day before and 4days after operation
Time Frame
baseline and 4 days
Title
Myoglobin
Description
1day before and 4days after operation
Time Frame
baseline and 4 days
Title
Troponin I
Description
1day before and 4days after operation
Time Frame
baseline and 4 days
Title
White Blood Cell
Description
1day before and 4days after operation
Time Frame
baseline and 4 days
Title
C-reactive protein
Description
1day before and 4days after operation
Time Frame
baseline and 4 days
Title
N-terminal B-type natriuretic peptide（NT-proBNP)
Description
1day before and 4days after operation
Time Frame
baseline and 4 days
Secondary Outcome Measure Information:
Title
Perioperative major adverse events
Time Frame
From pre-surgery to discharge, up to 4 weeks
Title
Perioperative use of vasoactive drug species
Time Frame
From pre-surgery to discharge, up to 4 weeks
Title
Vasoactive drugs Support Hours
Time Frame
From the start of drugs to stop them, up to 4 weeks
Title
Time after deactivation of vasoactive drugs
Time Frame
From the end of surgery to the deactivation of vasoactive drugs, up to 4 weeks
Title
Postoperative tracheal tube time
Time Frame
From the end of surgery to the removal of tracheal tube, up to 4 weeks
Title
Duration of mechanical ventilation after surgery
Time Frame
From the end of surgery to the recovery of spontaneous breathing, up to 4 weeks
Title
The time after the ICU until discharge
Time Frame
From leaving the ICU to discharge from hospital, up to 4 weeks
Title
Length of ICU stay
Time Frame
From ICU admission to discharge from ICU, up to 4 weeks
Title
Recovery time
Time Frame
From the end of surgery to recover, up to 4 weeks
Title
Time to first bowel movement
Time Frame
From the end of surgery to first bowel movement, up to 2 weeks
Title
Postoperative to normal eating time
Time Frame
From the end of surgery to normal eating, up to 2 weeks
Title
The total length of hospital stay
Time Frame
From admission to discharge, up to 5 weeks
Title
Visual analog pain score
Time Frame
From the end of surgery, up to 48 hours
Title
Ramsay score
Time Frame
From the end of surgery, up to 48 hours
Other Pre-specified Outcome Measures:
Title
The scores of mini-mental state examination
Time Frame
From the end of surgery, up to 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
e Wang, phD
Phone
+86 731 84327413
Email
ewang324@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
junjie Zhang, MD
Phone
+86 731 84327411
Email
proforol2199@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
e wang, phD
Organizational Affiliation
Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410078
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
17855198
Citation
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.
Results Reference
background
PubMed Identifier
10527232
Citation
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.
Results Reference
result
PubMed Identifier
18603748
Citation
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.
Results Reference
result
PubMed Identifier
11426357
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs