## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** LDing
#### Organization
**Class:** OTHER
**Full Name:** Beijing Hospital of Traditional Chinese Medicine
### Status Module
#### Completion Date
**Date:** 2023-09-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2021-08-24

**Type:** ACTUAL

**Last Update Submit Date:** 2021-08-20

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-09-01

**Type:** ESTIMATED

**Status Verified Date:** 2021-08

#### Study First Post Date
**Date:** 2021-08-24
**Type:** ACTUAL
**Study First Submit Date:** 2021-07-25
**Study First Submit QC Date:** 2021-08-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Lingling Ding

#### Responsible Party

**Investigator Affiliation:** Beijing Hospital of Traditional Chinese Medicine

**Investigator Full Name:** Lingling Ding

**Investigator Title:** Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Electroacupuncture

- Lung Injury, Ventilator Induced

**Keywords:**

- Electroacupuncture

- Lung protection

- ventilator induced lung injury

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 72

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Other: electroacupuncture

**Label:** electroacupuncture group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The patient underwent routine anesthesia without acupuncture treatment

**Label:** control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- electroacupuncture group

**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.

**Name:** electroacupuncture

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** record oxygenation index

**Measure:** oxygenation index

**Time Frame:** Before anesthesia

**Description:** record oxygenation index

**Measure:** oxygenation index

**Time Frame:** 2 hours after tracheal intubation

**Description:** record oxygenation index

**Measure:** oxygenation index

**Time Frame:** 5 minutes after tracheal intubation removal

#### Secondary Outcomes

**Description:** Assess the quality of recovery during recovery

**Measure:** Postoperative comfort score

**Time Frame:** during anesthesia recovery period

**Description:** Assess the quality of recovery during recovery

**Measure:** sedation score (Ramsay)

**Time Frame:** during anesthesia recovery period

**Description:** Assess the quality of recovery during recovery

**Measure:** restfulness score (DRS)

**Time Frame:** during anesthesia recovery period

**Description:** Assess the quality of recovery during recovery

**Measure:** visual analogue scale (VAS)

**Time Frame:** during anesthesia recovery period

**Description:** Assess the quality of postoperative recovery

**Measure:** Length of stay

**Time Frame:** 1 week after discharge, the patient's length of stay will be recorded through medical record system

**Description:** Assess the quality of postoperative recovery

**Measure:** postoperative time in hospital

**Time Frame:** 1 week after discharge, the patient's postoperative time in hospital will be recorded through medical record system

**Description:** Assess the quality of postoperative recovery

**Measure:** postoperative complications of major organs

**Time Frame:** Major organ complications during hospitalization，assessed up to 30 days after surgery

**Description:** Assess the quality of postoperative recovery

**Measure:** mortality within 30 days

**Time Frame:** mortality within 30 days will be recorded

**Description:** The perioperative inflammation level will be assessed

**Measure:** Expression of IL-18 in serum

**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

**Description:** The perioperative inflammation level will be assessed

**Measure:** Expression of IL-18 in serum

**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

**Description:** The perioperative inflammation level will be assessed

**Measure:** Expression of IL-1β in serum

**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

**Description:** The perioperative inflammation level will be assessed

**Measure:** Expression of IL-1β in serum

**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

**Description:** The perioperative inflammation level will be assessed

**Measure:** Expression of IL-10 in serum

**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

**Description:** The perioperative inflammation level will be assessed

**Measure:** Expression of IL-10 in serum

**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

**Description:** Intraoperative vital signs will be recorded

**Measure:** Mean arterial pressure

**Time Frame:** Before anesthesia ,2 hours after tracheal intubation , and 5minutes after tracheal intubation removal

**Description:** Intraoperative vital signs will be recorded

**Measure:** heart rate

**Time Frame:** Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal

**Description:** Intraoperative vital signs will be recorded

**Measure:** BIS

**Time Frame:** Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal

**Description:** Intraoperative vital signs will be recorded

**Measure:** extubation time

**Time Frame:** Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal

**Description:** Intraoperative vital signs will be recorded

**Measure:** anesthesia dosage

**Time Frame:** Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal

### Eligibility Module

**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.

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** dinglingling301@126.com

**Name:** Lingling Ding, Doctor

**Phone:** +86 010 52176647

**Role:** CONTACT

**Contact 2:**

**Email:** ningjiaqi95@163.com

**Name:** Jiaqi Ning, bachelor

**Phone:** +86 010 52176647

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000013898

- Term: Thoracic Injuries

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M28143

- Name: Lung Injury

- Relevance: HIGH

- As Found: Lung Injury

- ID: M28152

- Name: Ventilator-Induced Lung Injury

- Relevance: HIGH

- As Found: Lung Injury, Ventilator Induced

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16657

- Name: Thoracic Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000055370

- Term: Lung Injury

- ID: D000055397

- Term: Ventilator-Induced Lung Injury

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
