Evaluation of PC 6 "Neiguan" With Conventional Acupuncture to Prevent PONV After Laparoscopic Cholecystectomy.

NCT ID: NCT03088696

Last Updated: 2019-04-17

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-09-01

Brief Summary

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Assessment of the effectiveness of PC 6 "Neiguan" with conventional acupuncture for preventing PONV (PostOperative Nausea and Vomiting) after laparoscopic surgery.

Detailed Description

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Utilizing acustimulation, the effect of PC 6 "Neiguan" (acupuncture point Pericardium 6) has been studied in PONV . Conventional acupuncture has not been tested yet in laparoscopic cholecystectomy.

The incidence of postoperative vomiting during the first 24 hours is the main outcome. Secondary outcomes include: complete response rate, total rescue ondansetron dose used and patient satisfaction with PONV management.

Conditions

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Cholecystitis Vomiting Nausea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized comparative double blind prospective study
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The care provider get's an envelope from the study nurse when going to the patient in the operating room. Only the study nurse knows if an acupuncture needle is in the envelope.

Study Groups

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stimulation of the acupuncture point

a acupuncture needle and bandage will be applied at pericardium channel 6, point "Neiguan"

Group Type ACTIVE_COMPARATOR

stimulation

Intervention Type OTHER

activation of the acupuncture point

no stimulation of the acupuncture point

only a bandage will be applied at pericardium channel 6, point "Neiguan"

Group Type PLACEBO_COMPARATOR

no stimulation

Intervention Type OTHER

no activation of the acupuncture point

Interventions

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stimulation

activation of the acupuncture point

Intervention Type OTHER

no stimulation

no activation of the acupuncture point

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female and male patients
* \> 18 y
* General anesthesia
* Undergoing laparoscopic surgery
* Patient with American Society of Anesthesiologists physical status I-II
* Written informed consent

Exclusion Criteria

* Pregnant women and breastfeeding
* Patient with cardiac disease
* Surgery more than 2 h
* No bowel surgery
* Signs of skin infection at or near the purposed site of the acupuncture point
* Patient with American Society of Anesthesiologists physical status IIII-IV
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Veerle Van Mossevelde

Data Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Poelaert, PhD MD

Role: STUDY_CHAIR

Universitair Ziekenhuis Brussel

Güngör Badaş, Nurse

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Vincent Van Tittelboom, MD

Role: STUDY_DIRECTOR

Universitair Ziekenhuis Brussel

Philippe Bral, MD

Role: STUDY_DIRECTOR

Universitair Ziekenhuis Brussel

Locations

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Universitair Ziekenhuis Brussel

Jette, Vlaams-Brabant, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Veerle Van Mossevelde, Data Nurse

Role: CONTACT

+3224763134

Dirk De Clippeleir, Data Nurse

Role: CONTACT

+324763580

Facility Contacts

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Veerle Van Mossevelde, Study Nurse

Role: primary

+32 2 476 31 34

Other Identifiers

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Neiguan PC6

Identifier Type: -

Identifier Source: org_study_id

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