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
|Condition or disease||Intervention/treatment||Phase|
|Cholecystitis Vomiting Nausea||Other: stimulation Other: no stimulation||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|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.|
|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|
Active Comparator: stimulation of the acupuncture point
a acupuncture needle and bandage will be applied at pericardium channel 6, point "Neiguan"
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
- Vomiting and Nausea [ Time Frame: 24 hours ]numeric from 0-4, 0= no vomiting, 1= nausea, 2= moderate, 3= multiple and 4= extensive
- Use of antiemetic [ Time Frame: 24 hours ]dosage in mg
- Use of analgesia [ Time Frame: 24 hours ]dosage in mg
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
|Contact: Veerle Van Mossevelde, Data Nurseemail@example.com|
|Contact: Dirk De Clippeleir, Data Nursefirstname.lastname@example.org|
|Universitair Ziekenhuis Brussel||Recruiting|
|Jette, Vlaams-Brabant, Belgium, 1090|
|Contact: Veerle Van Mossevelde, Study Nurse +32 2 476 31 34 email@example.com|
|Principal Investigator: Güngor Badas, nurse|
|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|