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

April 16, 2019 updated by: Veerle Van Mossevelde, Universitair Ziekenhuis Brussel
Assessment of the effectiveness of PC 6 "Neiguan" with conventional acupuncture for preventing PONV (PostOperative Nausea and Vomiting) after laparoscopic surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Jette, Vlaams-Brabant, Belgium, 1090
        • Recruiting
        • Universitair Ziekenhuis Brussel
        • Contact:
        • Principal Investigator:
          • Güngor Badas, nurse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: stimulation of the acupuncture point
a acupuncture needle and bandage will be applied at pericardium channel 6, point "Neiguan"
Other: stimulation
activation of the acupuncture point
Placebo Comparator: no stimulation of the acupuncture point
only a bandage will be applied at pericardium channel 6, point "Neiguan"
Other: no stimulation
no activation of the acupuncture point

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vomiting and Nausea
Time Frame: 24 hours
numeric from 0-4, 0= no vomiting, 1= nausea, 2= moderate, 3= multiple and 4= extensive
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of antiemetic
Time Frame: 24 hours
dosage in mg
24 hours
Use of analgesia
Time Frame: 24 hours
dosage in mg
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Study Chair: Jan Poelaert, PhD MD, Universitair Ziekenhuis Brussel
  • Principal Investigator: Güngör Badaş, Nurse, Universitair Ziekenhuis Brussel
  • Study Director: Vincent Van Tittelboom, MD, Universitair Ziekenhuis Brussel
  • Study Director: Philippe Bral, MD, Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

March 7, 2017

First Submitted That Met QC Criteria

March 16, 2017

First Posted (Actual)

March 23, 2017

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neiguan PC6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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