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NCT03088696 Clinical Trial

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

Nausea Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03088696
Other study ID # Neiguan PC6
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date September 1, 2019

Study information
Verified date April 2019
Source Universitair Ziekenhuis Brussel
Contact Veerle Van Mossevelde, Data Nurse
Phone +3224763134
Email veerle.vanmossevelde@uzbrussel.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date September 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• stimulation
activation of the acupuncture point
• no stimulation
no activation of the acupuncture point

Locations
Country Name City State
Belgium Universitair Ziekenhuis Brussel Jette Vlaams-Brabant

Sponsors (1)
Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vomiting and Nausea numeric from 0-4, 0= no vomiting, 1= nausea, 2= moderate, 3= multiple and 4= extensive 24 hours
Secondary Use of antiemetic dosage in mg 24 hours
Secondary Use of analgesia dosage in mg 24 hours
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