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Clinical Trials/NCT02597842
NCT02597842
Unknown
Not Applicable

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

wangqiang1 site in 1 country180 target enrollmentDecember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Nausea and Vomiting
Sponsor
wangqiang
Enrollment
180
Locations
1
Primary Endpoint
The incidence of postoperative nausea and vomiting
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
October 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
wangqiang
Responsible Party
Sponsor Investigator
Principal Investigator

wangqiang

Professor

Xijing Hospital

Eligibility Criteria

Inclusion Criteria

  • Aged 18 to 65 years old
  • Scheduled for general anesthesia
  • BMI index is between 18 to 30
  • Informed consented

Exclusion Criteria

  • Hypertension that is not controlled
  • Severe hepatic or renal dysfunction
  • Ever had received electrical stimulation treatment
  • Severe systemic infection
  • With contraindications to the use of TEAS, such as skin damage or infection at the acupoints
  • For any reason one can not cope with the studies, such as the following:
  • language comprehension, mental illness
  • Participate in the other clinical trial 3 month before the enrollment

Outcomes

Primary Outcomes

The incidence of postoperative nausea and vomiting

Time Frame: within 24 hours after operation

Secondary Outcomes

  • 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)

Study Sites (1)

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