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Can Transcutaneous Electrical Acupoint Stimulation Improve the Quality of Recovery After Thyroidectomy?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02333747
First Posted: January 7, 2015
Last Update Posted: February 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yao Yusheng, Fujian Provincial Hospital
  Purpose
The effect of transcutaneous electric acupoint stimulation (TEAS) on the quality of recovery in patients undergoing thyroidectomy surgery remains unclear. Therefore, the investigators conducted this prospective, randomized, double-blind study to verify the hypothesis that pre-operative TEAS could improve the quality of recovery (QoR) after thyroidectomy surgery.

Condition Intervention
Postoperative Complications Device: the Hans electronic acupuncture apparatus

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Transcutaneous Electrical Acupoint Stimulation on the Quality of Recovery After Thyroidectomy Surgery

Resource links provided by NLM:


Further study details as provided by Yao Yusheng, Fujian Provincial Hospital:

Primary Outcome Measures:
  • the quality of recovery, as measured by a 40-item questionnaire [ Time Frame: 24 hours after surgery ]
    The primary outcome was the quality of recovery, which was assessed on the day before surgery and 24 h after surgery using a 40-item questionnaire (QoR-40)


Secondary Outcome Measures:
  • the incidence of postoperative nausea and vomiting [ Time Frame: 24 hours after surgery ]
  • postoperative pain intensity, as assessed using Visual Analogue Scale (VAS) [ Time Frame: 24 hours after surgery ]
  • patient's satisfaction, as evaluated with a 10-point numerical rating scale: 10= excellent, 1= bad. [ Time Frame: at 24 hours after surgery ]

Enrollment: 84
Study Start Date: January 2015
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: the TEAS group
Patients in the TEAS group received pre-operative TEAS for 30 min before the induction of anesthesia using the Hans electronic acupuncture apparatus (HANS-100A, Nanjing Jisheng Medical Technology Company, Nanjing, China) in the holding area. TEAS was applied to two pairs of acupoints: bilateral Hegu (LI4) and Neiguan (PC6).
Device: the Hans electronic acupuncture apparatus
TEAS was performed with a dense-disperse frequency of 2/10 Hz and an intensity of 6-9 mA for 30 min using the Hans electronic acupuncture apparatus (HANS-100A, Nanjing Jisheng Medical Technology Company, Nanjing, China).
Sham Comparator: the sham group
In the sham group, the patients were connected to the Hans electronic acupuncture apparatus (HANS-100A, Nanjing Jisheng Medical Technology Company, Nanjing, China), but electronic stimulation was not applied.
Device: the Hans electronic acupuncture apparatus
TEAS was performed with a dense-disperse frequency of 2/10 Hz and an intensity of 6-9 mA for 30 min using the Hans electronic acupuncture apparatus (HANS-100A, Nanjing Jisheng Medical Technology Company, Nanjing, China).

Detailed Description:
Transcutaneous electric acupoint stimulation (TEAS) is a form of non-invasive electrical stimulation that produces a perceptible sensation via electrodes attached to the skin. It has no risk of infections and can potentially be applied by medical personnel with minimal training. Clinical trials have demonstrated that TEAS reduces the consumption of intra-operative anesthetics and general anesthesia related side-effects.
  Eligibility

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive female patients aged 18 to 60 with American Society of Anesthesiologists physical status (ASA) physical status I or II, who underwent general anesthesia for elective thyroidectomy surgery

Exclusion Criteria:

  • potentially difficult airway,
  • a history of chronic pain,
  • drug or alcohol abuse,
  • mental disorder,
  • intake of any analgesic drug within 48 h before surgery, and
  • previous experience with acupuncture treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333747


Locations
China, Fujian
Fujian Provincial Hospital
Fuzhou, Fujian, China, 350001
Sponsors and Collaborators
Fujian Provincial Hospital
Investigators
Study Director: Yanqing Chen, MD Fujian Provincial Hospital, China
  More Information

Publications:
Responsible Party: Yao Yusheng, Professor, Fujian Provincial Hospital
ClinicalTrials.gov Identifier: NCT02333747     History of Changes
Other Study ID Numbers: K2014-12-003
First Submitted: January 2, 2015
First Posted: January 7, 2015
Last Update Posted: February 23, 2016
Last Verified: July 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes