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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03088696
Enrollment
200
Registered
2017-03-23
Start date
2018-02-01
Completion date
2019-09-01
Last updated
2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystitis, Vomiting, Nausea

Keywords

laparoscopic, acupuncture

Brief summary

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

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.

Interventions

activation of the acupuncture point

no activation of the acupuncture point

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, 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.

Intervention model description

randomized comparative double blind prospective study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Vomiting and Nausea24 hoursnumeric from 0-4, 0= no vomiting, 1= nausea, 2= moderate, 3= multiple and 4= extensive

Secondary

MeasureTime frameDescription
Use of antiemetic24 hoursdosage in mg
Use of analgesia24 hoursdosage in mg

Countries

Belgium

Contacts

Primary ContactVeerle Van Mossevelde, Data Nurse
veerle.vanmossevelde@uzbrussel.be+3224763134
Backup ContactDirk De Clippeleir, Data Nurse
dirk.declippeleir@uzbrussel.be+324763580

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026