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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05019079
Other study ID # LDing
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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