Protective Effect of Electroacupuncture on Lung in Patients Undergoing General Anesthesia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Protective Effect of Electroacupuncture on Lung in Patients Undergoing General Anesthesia

Conditions
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Electroacupuncture, Lung Injury, Ventilator Induced

Intervention / Treatment
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* Other: electroacupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electroacupuncture group<br>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. | Other: electroacupuncture<br>* 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.<br>|
| No Intervention: control group<br>The patient underwent routine anesthesia without acupuncture treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygenation index | record oxygenation index | Before anesthesia | 
| oxygenation index | record oxygenation index | 2 hours after tracheal intubation | 
| oxygenation index | record oxygenation index | 5 minutes after tracheal intubation removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative comfort score | Assess the quality of recovery during recovery | during anesthesia recovery period | 
| sedation score (Ramsay) | Assess the quality of recovery during recovery | during anesthesia recovery period | 
| restfulness score (DRS) | Assess the quality of recovery during recovery | during anesthesia recovery period | 
| visual analogue scale (VAS) | Assess the quality of recovery during recovery | during anesthesia recovery period | 
| Length of stay | Assess the quality of postoperative recovery | 1 week after discharge, the patient's length of stay will be recorded through medical record system | 
| postoperative time in hospital | Assess the quality of postoperative recovery | 1 week after discharge, the patient's postoperative time in hospital will be recorded through medical record system | 
| postoperative complications of major organs | Assess the quality of postoperative recovery | Major organ complications during hospitalization，assessed up to 30 days after surgery | 
| mortality within 30 days | Assess the quality of postoperative recovery | mortality within 30 days will be recorded | 
| Expression of IL-18 in serum | The perioperative inflammation level will be assessed | 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 | 
| Expression of IL-18 in serum | The perioperative inflammation level will be assessed | 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 | 
| Expression of IL-1β in serum | The perioperative inflammation level will be assessed | 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 | 
| Expression of IL-1β in serum | The perioperative inflammation level will be assessed | 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 | 
| Expression of IL-10 in serum | The perioperative inflammation level will be assessed | 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 | 
| Expression of IL-10 in serum | The perioperative inflammation level will be assessed | 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 | 
| Mean arterial pressure | Intraoperative vital signs will be recorded | Before anesthesia ,2 hours after tracheal intubation , and 5minutes after tracheal intubation removal | 
| heart rate | Intraoperative vital signs will be recorded | Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal | 
| BIS | Intraoperative vital signs will be recorded | Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal | 
| extubation time | Intraoperative vital signs will be recorded | Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal | 
| anesthesia dosage | Intraoperative vital signs will be recorded | Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electroacupuncture, Lung protection, ventilator induced lung injury