Protective Effect of Electroacupuncture on Lung in Patients Undergoing General Anesthesia

Electroacupuncture Clinical Trial

Official title:

Protective Effect of Electroacupuncture on Lung in Patients Undergoing General Anesthesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05019079
• Other study ID #: LDing
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: August 2021
• Source: Beijing Hospital of Traditional Chinese Medicine
• Contact: Lingling Ding, Doctor
• Phone: +86 010 52176647
• Email: dinglingling301[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients undergoing general anesthesia in our hospital;
• Ages 18-60;
• American Society of Anesthesiologists (ASA) grade ? ~ 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.

Related Conditions & MeSH terms

• Electroacupuncture
• Lung Injury
• Lung Injury, Ventilator Induced
• Ventilator-Induced Lung Injury

Intervention

Other:
• electroacupuncture
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lingling Ding

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygenation index	record oxygenation index	Before anesthesia
Primary	oxygenation index	record oxygenation index	2 hours after tracheal intubation
Primary	oxygenation index	record oxygenation index	5 minutes after tracheal intubation removal
Secondary	Postoperative comfort score	Assess the quality of recovery during recovery	during anesthesia recovery period
Secondary	sedation score (Ramsay)	Assess the quality of recovery during recovery	during anesthesia recovery period
Secondary	restfulness score (DRS)	Assess the quality of recovery during recovery	during anesthesia recovery period
Secondary	visual analogue scale (VAS)	Assess the quality of recovery during recovery	during anesthesia recovery period
Secondary	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
Secondary	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
Secondary	postoperative complications of major organs	Assess the quality of postoperative recovery	Major organ complications during hospitalization,assessed up to 30 days after surgery
Secondary	mortality within 30 days	Assess the quality of postoperative recovery	mortality within 30 days will be recorded
Secondary	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
Secondary	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
Secondary	Expression of IL-1ß 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-1ß in serum will be detected by flow cytometry
Secondary	Expression of IL-1ß 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-1ß in serum will be detected by flow cytometry
Secondary	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
Secondary	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
Secondary	Mean arterial pressure	Intraoperative vital signs will be recorded	Before anesthesia ,2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
Secondary	heart rate	Intraoperative vital signs will be recorded	Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
Secondary	BIS	Intraoperative vital signs will be recorded	Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
Secondary	extubation time	Intraoperative vital signs will be recorded	Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
Secondary	anesthesia dosage	Intraoperative vital signs will be recorded	Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal