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

NCT ID: NCT02333747

Last Updated: 2016-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

the Hans electronic acupuncture apparatus

Intervention Type DEVICE

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).

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.

Group Type SHAM_COMPARATOR

the Hans electronic acupuncture apparatus

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fujian Provincial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yao Yusheng

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Chen, MD

Role: STUDY_DIRECTOR

Fujian Provincial Hospital, China

Locations

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Fujian Provincial Hospital

Fuzhou, Fujian, China

Site Status

Countries

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China

References

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Chen Y, Yang Y, Yao Y, Dai D, Qian B, Liu P. Does transcutaneous electric acupoint stimulation improve the quality of recovery after thyroidectomy? A prospective randomized controlled trial. Int J Clin Exp Med. 2015 Aug 15;8(8):13622-7. eCollection 2015.

Reference Type RESULT
PMID: 26550304 (View on PubMed)

Other Identifiers

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K2014-12-003

Identifier Type: -

Identifier Source: org_study_id

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