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Electroacupuncture in Reducing the Dose of Analgesic in Patients Undergoing Off-pump Coronary Artery Bypass Grafting

Primary Purpose

Coronary Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TEAS (transcutaneous electric acupoint stimulation)
TEAS
TEAS
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists I-III
  • Scheduled for Off-Pump Coronary-Artery Bypass Grafting surgery
  • First thoracotomy
  • Signed written informed consent obtained

Exclusion Criteria:

  • American Society of Anesthesiologists IV
  • Undergoing surgery within 12 h of admission to hospital
  • Life expectancy < 1 year at the time of enrollment
  • Hemodynamic instability as defined by a systolic blood pressure <90 mmHg
  • Preoperative Intra-aortic Balloon Pumping or Ventricular Assisted Device
  • Severe hepatic or renal dysfunction
  • Not the first thoracotomy
  • Mediastinal fiber thickening or severe pleural adhesions
  • Severe adverse reactions
  • Severe systemic infection
  • With contraindications to the use of electroacupuncture, such as skin damage or infection at the acupoints
  • Suffering from nervous system disease or abnormal mental state
  • Participate in the other clinical trial 3 month before the enrollment

Sites / Locations

  • Xijing Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

distal-proximal group

regional group

control group

Arm Description

TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Hegu"

TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Juque"

no TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Hegu" .

Outcomes

Primary Outcome Measures

Dosage of sufentanil used during anesthesia
Dosage of sufentanil used during anesthesia

Secondary Outcome Measures

Evaluation of inotropic scores
inotropic drugs used postoperatively
Dosage of propofol used during anesthesia
Dosage of propofol used during anesthesia
Time of mechanical ventilation
length of mechanical ventilation postoperatively
In-hospital stay
It is the length of hospital stay postoperatively
Incidence of overall complication
Incidence of overall complication postoperatively
Incidence of overall mortality
Incidence of overall mortality postoperatively
The length of CCU stay
Length of CCU stay postoperatively
Heart rate during the anesthesia
Heart rate during the anesthesia
Mean arterial pressure during the anesthesia
Mean arterial pressure during the anesthesia
Bispectral index during the anesthesia
Bispectral index during the anesthesia
Incidence of overall complication
Incidence of overall complications postoperatively
Incidence of overall mortality
Incidence of overall mortality postoperatively

Full Information

First Posted
August 18, 2014
Last Updated
March 6, 2023
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02443220
Brief Title
Electroacupuncture in Reducing the Dose of Analgesic in Patients Undergoing Off-pump Coronary Artery Bypass Grafting
Official Title
Effects of Regional and Distant Combination of Acupoints Stimulated With Electroacupuncture on Patients Undergoing Off-pump Coronary Artery Bypass Grafting
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
September 6, 2018 (Actual)
Study Completion Date
October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A prospective, multiple-center, double-blinded, randomized, controlled clinical study to evaluate the antalgic effects between distal-proximal acupoints combination and regional acupoints combination stimulated with electroacupuncture on patients undergoing Off-Pump Coronary-Artery Bypass Grafting(OP-CABG).This clinical trial is to investigate whether electroacupuncture(EA) anesthesia can reduce analgesic in OP-CABG surgery in distal-proximal group.The origins of therapeutic acupuncture can be traced back at least 2,500 years in China. There has been an explosion of interest in Western medicine within the United States and Europe in application of acupuncture technique. Acupuncture enjoys worldwide acceptance for treating diseases such as migraine, chronic low back pain, and knee osteoarthritis. In 2002, WHO recommended 107 symptoms, syndromes, and diseases definitively shown to be effectively treated by acupuncture. Coronary heart disease (angina pectoris) is among these pathologies. A recent clinical trial demonstrated an acupuncture-assisted anesthesia strategy reduces postoperative morbidity and medical costs in open-heart surgery under cardiopulmonary bypass. Previous researches in animal models have demonstrated that electroacupuncture pretreatment protects the heart from ischemic injury. The investigators observed that electroacupuncture pretreatment (EAP, 30-minute electric stimulation through 4 electrodes attached to the bilateral forearm acupoints) before surgery significantly attenuated serum troponin levels during and shortly post-surgery in adult heart valve replacement patients and children undergoing cardiac surgery correcting congenital heart malformation.However, whether electroacupuncture anesthesia may reduce analgesic in OP-CABG surgery,especially in different combination of acupoints,has never been previously investigated.
Detailed Description
The anesthesia will be performed in a standard way. The propofol and sufentanil will be infused in target-controlled infusion mode. The dosage of analgesic will be assessed by the consumption of sufentanil. And the electroacupuncture anesthesia will be implemented by a device named "Hua Tuo" electronic acupuncture treatment instrument.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
315 (Actual)

8. Arms, Groups, and Interventions

Arm Title
distal-proximal group
Arm Type
Experimental
Arm Description
TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Hegu"
Arm Title
regional group
Arm Type
Active Comparator
Arm Description
TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Juque"
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
no TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Hegu" .
Intervention Type
Device
Intervention Name(s)
TEAS (transcutaneous electric acupoint stimulation)
Intervention Description
transcutaneous electric acupoint will commence at 30 min on "Danzhong" and "Hegu" before anesthesia in distal-proximal group
Intervention Type
Device
Intervention Name(s)
TEAS
Intervention Description
transcutaneous electric acupoint will commence at 30 min on "Danzhong" and "Juque" before anesthesia in regional group
Intervention Type
Device
Intervention Name(s)
TEAS
Intervention Description
The device will be connected to "Danzhong" and "Hegu" but no stimulation to the acupoints 30 min before anesthesia
Primary Outcome Measure Information:
Title
Dosage of sufentanil used during anesthesia
Description
Dosage of sufentanil used during anesthesia
Time Frame
during the anesthesia
Secondary Outcome Measure Information:
Title
Evaluation of inotropic scores
Description
inotropic drugs used postoperatively
Time Frame
24h postoperatively
Title
Dosage of propofol used during anesthesia
Description
Dosage of propofol used during anesthesia
Time Frame
During the anesthesia
Title
Time of mechanical ventilation
Description
length of mechanical ventilation postoperatively
Time Frame
at 30 days
Title
In-hospital stay
Description
It is the length of hospital stay postoperatively
Time Frame
at 30 days
Title
Incidence of overall complication
Description
Incidence of overall complication postoperatively
Time Frame
at 30 days
Title
Incidence of overall mortality
Description
Incidence of overall mortality postoperatively
Time Frame
at 30 days
Title
The length of CCU stay
Description
Length of CCU stay postoperatively
Time Frame
at 30 days
Title
Heart rate during the anesthesia
Description
Heart rate during the anesthesia
Time Frame
during the anesthesia
Title
Mean arterial pressure during the anesthesia
Description
Mean arterial pressure during the anesthesia
Time Frame
during the anesthesia
Title
Bispectral index during the anesthesia
Description
Bispectral index during the anesthesia
Time Frame
during the anesthesia
Title
Incidence of overall complication
Description
Incidence of overall complications postoperatively
Time Frame
at 1 year
Title
Incidence of overall mortality
Description
Incidence of overall mortality postoperatively
Time Frame
at 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists I-III Scheduled for Off-Pump Coronary-Artery Bypass Grafting surgery First thoracotomy Signed written informed consent obtained Exclusion Criteria: American Society of Anesthesiologists IV Undergoing surgery within 12 h of admission to hospital Life expectancy < 1 year at the time of enrollment Hemodynamic instability as defined by a systolic blood pressure <90 mmHg Preoperative Intra-aortic Balloon Pumping or Ventricular Assisted Device Severe hepatic or renal dysfunction Not the first thoracotomy Mediastinal fiber thickening or severe pleural adhesions Severe adverse reactions Severe systemic infection With contraindications to the use of electroacupuncture, such as skin damage or infection at the acupoints Suffering from nervous system disease or abnormal mental state Participate in the other clinical trial 3 month before the enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li ze Xiong, M.D.,Ph.D.
Organizational Affiliation
Xijing Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

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Electroacupuncture in Reducing the Dose of Analgesic in Patients Undergoing Off-pump Coronary Artery Bypass Grafting

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