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

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ClinicalTrials.gov Identifier: NCT03088696
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Veerle Van Mossevelde, Universitair Ziekenhuis Brussel

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

Condition or disease Intervention/treatment Phase
Cholecystitis Vomiting Nausea Other: stimulation Other: no stimulation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized comparative double blind prospective study
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Evaluation of PC 6 "Neiguan" With Conventional Acupuncture to Prevent PONV After Laparoscopic Cholecystectomy.
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Vomiting and Nausea [ Time Frame: 24 hours ]
    numeric from 0-4, 0= no vomiting, 1= nausea, 2= moderate, 3= multiple and 4= extensive


Secondary Outcome Measures :
  1. Use of antiemetic [ Time Frame: 24 hours ]
    dosage in mg

  2. Use of analgesia [ Time Frame: 24 hours ]
    dosage in mg



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088696


Contacts
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Contact: Veerle Van Mossevelde, Data Nurse +3224763134 veerle.vanmossevelde@uzbrussel.be
Contact: Dirk De Clippeleir, Data Nurse +324763580 dirk.declippeleir@uzbrussel.be

Locations
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Belgium
Universitair Ziekenhuis Brussel Recruiting
Jette, Vlaams-Brabant, Belgium, 1090
Contact: Veerle Van Mossevelde, Study Nurse    +32 2 476 31 34    veerle.vanmossevelde@uzbrussel.be   
Principal Investigator: Güngor Badas, nurse         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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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

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Responsible Party: Veerle Van Mossevelde, Data Nurse, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03088696     History of Changes
Other Study ID Numbers: Neiguan PC6
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Veerle Van Mossevelde, Universitair Ziekenhuis Brussel:
laparoscopic
acupuncture

Additional relevant MeSH terms:
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Vomiting
Cholecystitis
Acalculous Cholecystitis
Signs and Symptoms, Digestive
Signs and Symptoms
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases