Back to resultsProtective Effect of Electroacupuncture on Lung in Patients Undergoing General Anesthesia
Primary Purpose
Electroacupuncture, Lung Injury, Ventilator Induced
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
electroacupuncture
Sponsored by
About this trial
This is an interventional prevention trial for Electroacupuncture focused on measuring Electroacupuncture, Lung protection, ventilator induced lung injury
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing general anesthesia in our hospital;
- Ages 18-60;
- American Society of Anesthesiologists (ASA) grade ⅱ ~ III , no severe respiratory, circulation, liver, kidney, coagulation function abnormalities;
- Expected duration of operation >2h;
- Surgical grade 2-4;
- No serious lung infection and lung disease;
- Body mass index (BMI) 18~30 kg/m2; There are no contraindications for electroacupuncture stimulation.
Exclusion Criteria:
- Patients with severe circulatory or other system dysfunction;
- Patients with pulmonary and one-lung ventilation;
- Unwilling to cooperate with the patient;
- Patients with low compliance.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
electroacupuncture group
control group
Arm Description
In the electroacupuncture group, acupoints of Lieque (+), Chize (-), Sanyinjiao (-), Zusanli (+), Tanzhong (+) and Yutang (-) will be selected for electrical stimulation. Density wave will be selected, and the current intensity should be tolerated by the patients. Conventional anesthesia operation could be started after the connection of electroacupuncture, and acupuncture point stimulation was stopped 30min later.
The patient underwent routine anesthesia without acupuncture treatment
Outcomes
Primary Outcome Measures
oxygenation index
record oxygenation index
oxygenation index
record oxygenation index
oxygenation index
record oxygenation index
Secondary Outcome Measures
Postoperative comfort score
Assess the quality of recovery during recovery
sedation score (Ramsay)
Assess the quality of recovery during recovery
restfulness score (DRS)
Assess the quality of recovery during recovery
visual analogue scale (VAS)
Assess the quality of recovery during recovery
Length of stay
Assess the quality of postoperative recovery
postoperative time in hospital
Assess the quality of postoperative recovery
postoperative complications of major organs
Assess the quality of postoperative recovery
mortality within 30 days
Assess the quality of postoperative recovery
Expression of IL-18 in serum
The perioperative inflammation level will be assessed
Expression of IL-18 in serum
The perioperative inflammation level will be assessed
Expression of IL-1β in serum
The perioperative inflammation level will be assessed
Expression of IL-1β in serum
The perioperative inflammation level will be assessed
Expression of IL-10 in serum
The perioperative inflammation level will be assessed
Expression of IL-10 in serum
The perioperative inflammation level will be assessed
Mean arterial pressure
Intraoperative vital signs will be recorded
heart rate
Intraoperative vital signs will be recorded
BIS
Intraoperative vital signs will be recorded
extubation time
Intraoperative vital signs will be recorded
anesthesia dosage
Intraoperative vital signs will be recorded
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05019079
Brief Title
Protective Effect of Electroacupuncture on Lung in Patients Undergoing General Anesthesia
Official Title
Protective Effect of Electroacupuncture on Lung in Patients Undergoing General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lingling Ding
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objective to investigate the protective effect of preoperative electroacupuncture on lung function in patients with mechanical ventilation for more than 2 hours under general anesthesia
Detailed Description
Randomized parallel control study. From September 1, 2021 to December 31, 2022, patients with mechanical ventilation time more than 2 hours will be randomly divided into electroacupuncture pretreatment group and blank control group. The blood gas index, ventilator parameters and serum inflammatory factor concentration of patients will be evaluated to evaluate whether electroacupuncture has protective effect on lung function of patients with mechanical ventilation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Electroacupuncture, Lung Injury, Ventilator Induced
Keywords
Electroacupuncture, Lung protection, ventilator induced lung injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
electroacupuncture group
Arm Type
Experimental
Arm Description
In the electroacupuncture group, acupoints of Lieque (+), Chize (-), Sanyinjiao (-), Zusanli (+), Tanzhong (+) and Yutang (-) will be selected for electrical stimulation. Density wave will be selected, and the current intensity should be tolerated by the patients. Conventional anesthesia operation could be started after the connection of electroacupuncture, and acupuncture point stimulation was stopped 30min later.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The patient underwent routine anesthesia without acupuncture treatment
Intervention Type
Other
Intervention Name(s)
electroacupuncture
Intervention Description
In the electroacupuncture group, acupoints of Lieque (+), Chize (-), Sanyinjiao (-), Zusanli (+), Tanzhong (+) and Yutang (-) will be selected for electrical stimulation. Density wave will be selected, and the current intensity should be tolerated by the patients. Conventional anesthesia operation could be started after the connection of electroacupuncture, and acupuncture point stimulation will be stopped 30min later.
Primary Outcome Measure Information:
Title
oxygenation index
Description
record oxygenation index
Time Frame
Before anesthesia
Title
oxygenation index
Description
record oxygenation index
Time Frame
2 hours after tracheal intubation
Title
oxygenation index
Description
record oxygenation index
Time Frame
5 minutes after tracheal intubation removal
Secondary Outcome Measure Information:
Title
Postoperative comfort score
Description
Assess the quality of recovery during recovery
Time Frame
during anesthesia recovery period
Title
sedation score (Ramsay)
Description
Assess the quality of recovery during recovery
Time Frame
during anesthesia recovery period
Title
restfulness score (DRS)
Description
Assess the quality of recovery during recovery
Time Frame
during anesthesia recovery period
Title
visual analogue scale (VAS)
Description
Assess the quality of recovery during recovery
Time Frame
during anesthesia recovery period
Title
Length of stay
Description
Assess the quality of postoperative recovery
Time Frame
1 week after discharge, the patient's length of stay will be recorded through medical record system
Title
postoperative time in hospital
Description
Assess the quality of postoperative recovery
Time Frame
1 week after discharge, the patient's postoperative time in hospital will be recorded through medical record system
Title
postoperative complications of major organs
Description
Assess the quality of postoperative recovery
Time Frame
Major organ complications during hospitalization，assessed up to 30 days after surgery
Title
mortality within 30 days
Description
Assess the quality of postoperative recovery
Time Frame
mortality within 30 days will be recorded
Title
Expression of IL-18 in serum
Description
The perioperative inflammation level will be assessed
Time Frame
Before anesthetic induction the radial artery blood samples will be collected, and the expressions of IL-18 in serum will be detected by flow cytometry
Title
Expression of IL-18 in serum
Description
The perioperative inflammation level will be assessed
Time Frame
5minutes after tracheal intubation removal the radial artery blood samples will be collected, and the expressions of IL-18 in serum will be detected by flow cytometry
Title
Expression of IL-1β in serum
Description
The perioperative inflammation level will be assessed
Time Frame
Before anesthetic induction the radial artery blood samples will be collected, and the expressions of IL-1β in serum will be detected by flow cytometry
Title
Expression of IL-1β in serum
Description
The perioperative inflammation level will be assessed
Time Frame
5minutes after tracheal intubation removal the radial artery blood samples will be collected, and the expressions of IL-1β in serum will be detected by flow cytometry
Title
Expression of IL-10 in serum
Description
The perioperative inflammation level will be assessed
Time Frame
Before anesthetic induction the radial artery blood samples will be collected, and the expressions of IL-10 in serum will be detected by flow cytometry
Title
Expression of IL-10 in serum
Description
The perioperative inflammation level will be assessed
Time Frame
5minutes after tracheal intubation removal the radial artery blood samples will be collected, and the expressions of IL-10 in serum will be detected by flow cytometry
Title
Mean arterial pressure
Description
Intraoperative vital signs will be recorded
Time Frame
Before anesthesia ,2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
Title
heart rate
Description
Intraoperative vital signs will be recorded
Time Frame
Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
Title
BIS
Description
Intraoperative vital signs will be recorded
Time Frame
Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
Title
extubation time
Description
Intraoperative vital signs will be recorded
Time Frame
Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
Title
anesthesia dosage
Description
Intraoperative vital signs will be recorded
Time Frame
Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing general anesthesia in our hospital;
Ages 18-60;
American Society of Anesthesiologists (ASA) grade ⅱ ~ III , no severe respiratory, circulation, liver, kidney, coagulation function abnormalities;
Expected duration of operation >2h;
Surgical grade 2-4;
No serious lung infection and lung disease;
Body mass index (BMI) 18~30 kg/m2; There are no contraindications for electroacupuncture stimulation.
Exclusion Criteria:
Patients with severe circulatory or other system dysfunction;
Patients with pulmonary and one-lung ventilation;
Unwilling to cooperate with the patient;
Patients with low compliance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lingling Ding, Doctor
Phone
+86 010 52176647
Email
dinglingling301@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jiaqi Ning, bachelor
Phone
+86 010 52176647
Email
ningjiaqi95@163.com
12. IPD Sharing Statement
Learn more about this trial
Protective Effect of Electroacupuncture on Lung in Patients Undergoing General Anesthesia
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