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

NCT ID: NCT02597842

Last Updated: 2015-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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shuangxuezu

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

Group Type EXPERIMENTAL

TEAS (transcutaneous electrical acupoint stimulation)

Intervention Type DEVICE

Electric stimulation was given through electrode attached to specific acupoints

neiguanxuezu

Patients were given TEAS at neiguan acupoint.

Group Type EXPERIMENTAL

TEAS (transcutaneous electrical acupoint stimulation)

Intervention Type DEVICE

Electric stimulation was given through electrode attached to specific acupoints

zusanlixuezu

Patients were given TEAS at Zusanli acupoint.

Group Type EXPERIMENTAL

TEAS (transcutaneous electrical acupoint stimulation)

Intervention Type DEVICE

Electric stimulation was given through electrode attached to specific acupoints

duizhaozu

Patients were not given TEAS at two acupoints.

Group Type SHAM_COMPARATOR

TEAS (transcutaneous electrical acupoint stimulation)

Intervention Type DEVICE

Electric stimulation was given through electrode attached to specific acupoints

Interventions

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TEAS (transcutaneous electrical acupoint stimulation)

Electric stimulation was given through electrode attached to specific acupoints

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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wangqiang

OTHER

Sponsor Role lead

Responsible Party

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wangqiang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lizhe Xiong, M.D.;Ph D

Role: STUDY_CHAIR

Air Force Military Medical University, China

Locations

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Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status

Countries

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China

Central Contacts

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Haifeng Duan

Role: CONTACT

15091626182

Zhihong Lu, M.D.;Ph D

Role: CONTACT

029-84775343

Facility Contacts

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Hailong Dong, M.D., Ph.D.

Role: primary

86-29-84775337

Lize Xiong, M.D., Ph.D.

Role: backup

+86-29-84775337

Other Identifiers

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xijingmazui79

Identifier Type: -

Identifier Source: org_study_id

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