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

Not Applicable

Completed

• Conditions: Postoperative Complications
• Interventions: Device: the Hans electronic acupuncture apparatus

• Registration Number: NCT02333747
• Lead Sponsor: Fujian Provincial Hospital

Brief 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.

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-02
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-07
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-07
• Last Update Submitted: 2016-02-21
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the TEAS group	the Hans electronic acupuncture apparatus	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).
the sham group	the Hans electronic acupuncture apparatus	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.

Primary Outcome Measures

Name	Time	Method
the quality of recovery, as measured by a 40-item questionnaire	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

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

Trial Locations

Locations (1)

Fujian Provincial Hospital; 🇨🇳 Fuzhou, Fujian, China