Clinical trial NCT05019079: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Electroacupuncture
Lung Injury, Ventilator Induced
Keywords: Electroacupuncture
Lung protection
ventilator induced lung injury
Lead sponsor: Beijing Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: oxygenation index
timeFrame: Before anesthesia
measure: oxygenation index
timeFrame: 2 hours after tracheal intubation
measure: oxygenation index
timeFrame: 5 minutes after tracheal intubation removal
Secondary outcomes:
measure: Postoperative comfort score
timeFrame: during anesthesia recovery period
measure: sedation score (Ramsay)
timeFrame: during anesthesia recovery period
measure: restfulness score (DRS)
timeFrame: during anesthesia recovery period
measure: visual analogue scale (VAS)
timeFrame: during anesthesia recovery period
measure: Length of stay
timeFrame: 1 week after discharge, the patient's length of stay will be recorded through medical record system
measure: postoperative time in hospital
timeFrame: 1 week after discharge, the patient's postoperative time in hospital will be recorded through medical record system
measure: postoperative complications of major organs
timeFrame: Major organ complications during hospitalization，assessed up to 30 days after surgery
measure: mortality within 30 days
timeFrame: mortality within 30 days will be recorded
measure: Expression of IL-18 in serum
timeFrame: 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
measure: Expression of IL-18 in serum
timeFrame: 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
measure: Expression of IL-1β in serum
timeFrame: 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
measure: Expression of IL-1β in serum
timeFrame: 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
measure: Expression of IL-10 in serum
timeFrame: 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
measure: Expression of IL-10 in serum
timeFrame: 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
measure: Mean arterial pressure
timeFrame: Before anesthesia ,2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
measure: heart rate
timeFrame: Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
measure: BIS
timeFrame: Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
measure: extubation time
timeFrame: Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
measure: anesthesia dosage
timeFrame: Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
Other outcomes:
Locations:
Study officials:
References: