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

Postoperative Complications Clinical Trial

Official title:

The Effects of Transcutaneous Electrical Acupoint Stimulation on the Quality of Recovery After Thyroidectomy Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02333747
• Other study ID #: K2014-12-003
• Status: Completed
• Phase: N/A
• First received: January 2, 2015
• Last updated: February 21, 2016
• Start date: January 2015
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: Fujian Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

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).

Locations

Country	Name	City	State
China	Fujian Provincial Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Provincial Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the quality of recovery, as measured by a 40-item questionnaire	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)	24 hours after surgery	No
Secondary	the incidence of postoperative nausea and vomiting		24 hours after surgery	No
Secondary	postoperative pain intensity, as assessed using Visual Analogue Scale (VAS)		24 hours after surgery	No
Secondary	patient's satisfaction, as evaluated with a 10-point numerical rating scale: 10= excellent, 1= bad.		at 24 hours after surgery	No