Protective Effect of Electroacupuncture on Lung in Patients Undergoing General Anesthesia

Sponsor
Lingling Ding (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05019079
Collaborator
(none)
72
2
24

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: electroacupuncture
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Protective Effect of Electroacupuncture on Lung in Patients Undergoing General Anesthesia
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: electroacupuncture group

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
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.

No Intervention: control group

The patient underwent routine anesthesia without acupuncture treatment

Outcome Measures

Primary Outcome Measures

  1. oxygenation index [Before anesthesia]

    record oxygenation index

  2. oxygenation index [2 hours after tracheal intubation]

    record oxygenation index

  3. oxygenation index [5 minutes after tracheal intubation removal]

    record oxygenation index

Secondary Outcome Measures

  1. Postoperative comfort score [during anesthesia recovery period]

    Assess the quality of recovery during recovery

  2. sedation score (Ramsay) [during anesthesia recovery period]

    Assess the quality of recovery during recovery

  3. restfulness score (DRS) [during anesthesia recovery period]

    Assess the quality of recovery during recovery

  4. visual analogue scale (VAS) [during anesthesia recovery period]

    Assess the quality of recovery during recovery

  5. Length of stay [1 week after discharge, the patient's length of stay will be recorded through medical record system]

    Assess the quality of postoperative recovery

  6. postoperative time in hospital [1 week after discharge, the patient's postoperative time in hospital will be recorded through medical record system]

    Assess the quality of postoperative recovery

  7. postoperative complications of major organs [Major organ complications during hospitalization,assessed up to 30 days after surgery]

    Assess the quality of postoperative recovery

  8. mortality within 30 days [mortality within 30 days will be recorded]

    Assess the quality of postoperative recovery

  9. Expression of IL-18 in serum [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]

    The perioperative inflammation level will be assessed

  10. Expression of IL-18 in serum [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]

    The perioperative inflammation level will be assessed

  11. Expression of IL-1β in serum [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]

    The perioperative inflammation level will be assessed

  12. Expression of IL-1β in serum [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]

    The perioperative inflammation level will be assessed

  13. Expression of IL-10 in serum [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]

    The perioperative inflammation level will be assessed

  14. Expression of IL-10 in serum [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]

    The perioperative inflammation level will be assessed

  15. Mean arterial pressure [Before anesthesia ,2 hours after tracheal intubation , and 5minutes after tracheal intubation removal]

    Intraoperative vital signs will be recorded

  16. heart rate [Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal]

    Intraoperative vital signs will be recorded

  17. BIS [Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal]

    Intraoperative vital signs will be recorded

  18. extubation time [Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal]

    Intraoperative vital signs will be recorded

  19. anesthesia dosage [Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal]

    Intraoperative vital signs will be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Lingling Ding

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lingling Ding, Professor, Beijing Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT05019079
Other Study ID Numbers:
  • LDing
First Posted:
Aug 24, 2021
Last Update Posted:
Aug 24, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lingling Ding, Professor, Beijing Hospital of Traditional Chinese Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2021