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

March 29, 2016 updated by: Xiangya Hospital of Central South University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410078
        • Xiangya Hospital of Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fasting blood glucose
Time Frame: baseline and 4 days
1day before and 4days after operation
baseline and 4 days
Blood Lactic Acid
Time Frame: baseline and 4 days
1day before and 4days after operation
baseline and 4 days
Creatine kinase isoenzymes
Time Frame: baseline and 4 days
1day before and 4days after operation
baseline and 4 days
Myoglobin
Time Frame: baseline and 4 days
1day before and 4days after operation
baseline and 4 days
Troponin I
Time Frame: baseline and 4 days
1day before and 4days after operation
baseline and 4 days
White Blood Cell
Time Frame: baseline and 4 days
1day before and 4days after operation
baseline and 4 days
C-reactive protein
Time Frame: baseline and 4 days
1day before and 4days after operation
baseline and 4 days
N-terminal B-type natriuretic peptide（NT-proBNP)
Time Frame: baseline and 4 days
1day before and 4days after operation
baseline and 4 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Perioperative major adverse events
Time Frame: From pre-surgery to discharge, up to 4 weeks
From pre-surgery to discharge, up to 4 weeks
Vasoactive drugs Support Hours
Time Frame: From the start of drugs to stop them, up to 4 weeks
From the start of drugs to stop them, up to 4 weeks
Postoperative tracheal tube time
Time Frame: From the end of surgery to the removal of tracheal tube, up to 4 weeks
From the end of surgery to the removal of tracheal tube, up to 4 weeks
Duration of mechanical ventilation after surgery
Time Frame: From the end of surgery to the recovery of spontaneous breathing, up to 4 weeks
From the end of surgery to the recovery of spontaneous breathing, up to 4 weeks
Perioperative use of vasoactive drug species
Time Frame: From pre-surgery to discharge, up to 4 weeks
From pre-surgery to discharge, up to 4 weeks
Time after deactivation of vasoactive drugs
Time Frame: From the end of surgery to the deactivation of vasoactive drugs, up to 4 weeks
From the end of surgery to the deactivation of vasoactive drugs, up to 4 weeks
The time after the ICU until discharge
Time Frame: From leaving the ICU to discharge from hospital, up to 4 weeks
From leaving the ICU to discharge from hospital, up to 4 weeks
Length of ICU stay
Time Frame: From ICU admission to discharge from ICU, up to 4 weeks
From ICU admission to discharge from ICU, up to 4 weeks
Recovery time
Time Frame: From the end of surgery to recover, up to 4 weeks
From the end of surgery to recover, up to 4 weeks
Time to first bowel movement
Time Frame: From the end of surgery to first bowel movement, up to 2 weeks
From the end of surgery to first bowel movement, up to 2 weeks
Postoperative to normal eating time
Time Frame: From the end of surgery to normal eating, up to 2 weeks
From the end of surgery to normal eating, up to 2 weeks
The total length of hospital stay
Time Frame: From admission to discharge, up to 5 weeks
From admission to discharge, up to 5 weeks
Visual analog pain score
Time Frame: From the end of surgery, up to 48 hours
From the end of surgery, up to 48 hours
Ramsay score
Time Frame: From the end of surgery, up to 48 hours
From the end of surgery, up to 48 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
The scores of mini-mental state examination
Time Frame: From the end of surgery, up to 48 hours
From the end of surgery, up to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiangya Hospital of Central South University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: e wang, phD, Xiangya Hospital of Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20160131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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