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

Not Applicable

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Device: TEAS (transcutaneous electrical acupoint stimulation)

• Registration Number: NCT02597842
• Lead Sponsor: wangqiang

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2015-11
• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-04
• Last Update Submitted: 2015-11-04
• Study First Posted: 2015-11-05
• Last Update Posted: 2015-11-05
• Study Start: 2015-12
• Primary Completion: 2016-08
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
shuangxuezu	TEAS (transcutaneous electrical acupoint stimulation)	Patients were given 30min of TEAS before induction until the end of the operation at two acupoints.
neiguanxuezu	TEAS (transcutaneous electrical acupoint stimulation)	Patients were given TEAS at neiguan acupoint.
zusanlixuezu	TEAS (transcutaneous electrical acupoint stimulation)	Patients were given TEAS at Zusanli acupoint.
duizhaozu	TEAS (transcutaneous electrical acupoint stimulation)	Patients were not given TEAS at two acupoints.

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative nausea and vomiting	within 24 hours after operation

Secondary Outcome Measures

Name	Time	Method
Change of concentration of serum 5-HT	intraoperative
Change of concentration of serum dopamine	intraoperative
Incidence of other postoperative complications	30minutes, 2hours, 6hours and 24 hours after operation
Postoperative nausea and vomiting（PONV） score	30minutes, 2hours, 6hours and 24 hours after operation
Visual Analogue Scale (VAS) pain score in PACU	30 minutes after operation

Trial Locations

Locations (1)

Xijing Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China