Transcutaneous Electrical Acupoint Stimulation(TEAS) for Postoperative Nausea and Vomiting in Laparoscopic Operation

Postoperative Nausea and Vomiting Clinical Trial

Official title:

Efficiency of Transcutaneous Electrical Acupoint Stimulation(TEAS) With Single Acupoint or Two Acupoints for Postoperative Nausea and Vomiting in Laparoscopic Operation: A Single Center, Randomized, Double-blinded, Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02597842
• Other study ID #: xijingmazui79
• Status: Not yet recruiting
• Phase: N/A
• First received: November 3, 2015
• Last updated: November 4, 2015
• Start date: December 2015
• Est. completion date: October 2016

Study information

• Verified date: November 2015
• Source: Xijing Hospital
• Contact: Haifeng Duan
• Phone: 15091626182
• Email: 875939063[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This is a single center, randomized, double-blinded, controlled clinical trial.The purpose of this study is to compare the effect of TEAS pretreatment with single acupoint or two acupoints for postoperative nausea and vomiting in patients undergoing laparoscopic operation.

Description:

Patients were randomly assigned to four groups, receiving TEAS 30 minutes before induction.The stimulation was applied until the end of the operation. Postoperative nausea and vomiting was recorded 30 minute, 2 hour, 6 hour and 24 hour after the operation. The adverse events were recorded as well.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. ASA I-III

2. Aged 18 to 65 years old

3. Scheduled for general anesthesia

4. BMI index is between 18 to 30

5. Informed consented

Exclusion Criteria:

1. ASA IV

2. Hypertension that is not controlled

3. Severe hepatic or renal dysfunction

4. Ever had received electrical stimulation treatment

5. Severe systemic infection

6. With contraindications to the use of TEAS, such as skin damage or infection at the acupoints

7. For any reason one can not cope with the studies, such as the following:

language comprehension, mental illness

8. Participate in the other clinical trial 3 month before the enrollment

Study Design

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Device:
• TEAS (transcutaneous electrical acupoint stimulation)
Electric stimulation was given through electrode attached to specific acupoints

Locations

Country	Name	City	State
China	Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
wangqiang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of postoperative nausea and vomiting		within 24 hours after operation	No
Secondary	Incidence of other postoperative complications		30minutes, 2hours, 6hours and 24 hours after operation	No
Secondary	Postoperative nausea and vomiting(PONV) score		30minutes, 2hours, 6hours and 24 hours after operation	No
Secondary	Visual Analogue Scale (VAS) pain score in PACU		30 minutes after operation	Yes
Secondary	Change of concentration of serum 5-HT		intraoperative	No
Secondary	Change of concentration of serum dopamine		intraoperative	No