NCT02850471

Brief Summary

TEAS might protect against postoperative pulmonary such as ischemia-reperfusion injury (IRI) and atelectasis. We tested the hypothesis that transcutaneous electrical acupoint stimulation protects against postoperative pulmonary complications in patients who are receiving mechanical ventilation during general anesthesia for gynecologic laparoscopic surgery.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 1, 2016

Status Verified

July 1, 2016

Enrollment Period

9 months

First QC Date

July 21, 2016

Last Update Submit

July 29, 2016

Conditions

Reperfusion Injury

Keywords

Postoperative pulmonary complicationsTranscutaneous electric acupoint stimulationpulmonary protection

Outcome Measures

Primary Outcomes (6)

  • the change of hemodynamic parameter MAP in mmHg

    intraoperative

  • the change of hemodynamic parameters HR in beat per minutes

    intraoperative

  • the change of blood SPO2 in percentage

    intraoperative

  • the change of blood pH

    intraoperative

  • the change of blood PCO2 in mmHg

    intraoperative

  • the change of blood PO2 in mmHg

    intraoperative

Secondary Outcomes (3)

  • the change of Plasma concentration of TNF-α in pg/mL

    intraoperative

  • post-operative pulmonary complications

    in the first 5 days after surgery

  • the change of plasma concentration of IL-1β

    intraoperative

Study Arms (2)

TEAS group

EXPERIMENTAL

Before anesthesia, patients in this group treated with Transcutaneous Electric Acupoint Stimulation (TEAS) which is an electroacupuncture on Feishu, Hegu, Chize half an hour before the surgery, using the device Hua Tuo SDZ-II Acupoint Stimulator. The stimulus parameters set as 2/100Hz, 2V, 30min.

Device: electroacupuncture

controlled group

NO INTERVENTION

Patients in controlled group treated without TEAS or other placebo.

Interventions

electroacupunctureDEVICE

Transcutaneous Electric Acupoint Stimulation which is a device of electroacupuncture was used on patients in TEAS group with the stimulator parameters set as 2/100Hz, 2V, 30min.

TEAS group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged from 65 to 75
  • The American Society of anesthesiologists (American Society of Anesthesiology, ASA) class Ⅱ \~ III
  • scheduled for gynecologic laparoscopic surgery under general anesthesia

You may not qualify if:

  • pre-existing lung or caridac disease
  • impaired kidney or liver function
  • history of bronchial asthma or chronic obstructive pulmonary disease
  • history of smoking
  • respiratory infection in the previous 2 weeks
  • preoperative use of bronchodilator, or a steroid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing hospital of China medical university

Shenyang, Liaoning, 110000, China

Location

Related Publications (1)

  • Wei W, Bai W, Yang Y, Li Y, Teng X, Wan Y, Zhu J. Pulmonary protection of transcutaneous electrical acupoint stimulation in gynecological laparoscopic surgery: A randomized controlled trial. Exp Ther Med. 2020 Jan;19(1):511-518. doi: 10.3892/etm.2019.8245. Epub 2019 Nov 26.

    PMID: 31885697DERIVED

MeSH Terms

Conditions

Reperfusion Injury

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Junchao Zhu, doctor

    professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

July 21, 2016

First Posted

August 1, 2016

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

August 1, 2016

Last Updated

August 1, 2016

Record last verified: 2016-07

Locations

CN(1)