NCT02597842

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
26 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 5, 2015

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

November 3, 2015

Last Update Submit

November 4, 2015

Conditions

Postoperative Nausea and Vomiting

Keywords

Postoperative nausea and vomitingTEAS

Outcome Measures

Primary Outcomes (1)

  • The incidence of postoperative nausea and vomiting

    within 24 hours after operation

Secondary Outcomes (5)

  • 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

  • Change of concentration of serum 5-HT

    intraoperative

  • Change of concentration of serum dopamine

    intraoperative

Study Arms (4)

shuangxuezu

EXPERIMENTAL

Patients were given 30min of TEAS before induction until the end of the operation at two acupoints.

Device: TEAS (transcutaneous electrical acupoint stimulation)

neiguanxuezu

EXPERIMENTAL

Patients were given TEAS at neiguan acupoint.

Device: TEAS (transcutaneous electrical acupoint stimulation)

zusanlixuezu

EXPERIMENTAL

Patients were given TEAS at Zusanli acupoint.

Device: TEAS (transcutaneous electrical acupoint stimulation)

duizhaozu

SHAM COMPARATOR

Patients were not given TEAS at two acupoints.

Device: TEAS (transcutaneous electrical acupoint stimulation)

Interventions

TEAS (transcutaneous electrical acupoint stimulation)DEVICE

Electric stimulation was given through electrode attached to specific acupoints

duizhaozuneiguanxuezushuangxuezuzusanlixuezu

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • ASA IV
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Officials

  • Lizhe Xiong, M.D.;Ph D

    Air Force Military Medical University, China

    STUDY CHAIR

Central Study Contacts

Haifeng Duan

CONTACT

15091626182875939063@qq.com

Zhihong Lu, M.D.;Ph D

CONTACT

029-84775343deerlu@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 3, 2015

First Posted

November 5, 2015

Study Start

December 1, 2015

Primary Completion

August 1, 2016

Study Completion

October 1, 2016

Last Updated

November 5, 2015

Record last verified: 2015-11

Locations

CN(1)