The aim of the study is to investigate if P6 acupuncture made after induction of general anaesthesia might be effective for the prevention of PONV as ondansetron and if the acupuncture-ondansetron combination could enhance single therapy efficacy in patients undergoing laparoscopic cholecystectomy.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment

Study Primary Completion Date: September 2007

Intervention(s) in this Clinical Trial

• Other: Acupuncture
• Drug: Ondansetron
• Drug: Physiological saline solution
• Other: Sham acupuncture
• Drug: Ondansetron
• Other: Acupuncture at P6 point
• Drug: Physiological saline solution
• Other: Sham acupuncture

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Patients receiving acupuncture at P6 point plus physiological saline solution
• Active Comparator: B
  • Patients receiving ondansetron plus sham acupuncture
• Other: C
  • Patients receiving ondansetron plus acupuncture at P6 point
• Placebo Comparator: D
  • Patients receiving physiological saline solution plus sham acupuncture

Primary Measures

• postoperative nausea and vomiting
  • Time Frame: 24 postoperative hours
    Safety Issue?: No

Inclusion Criteria:

• Patients ASA I-II scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria:

• Patient's refusal
• Patients with history of carpal tunnel syndrome or eczema at P6 point
• Pregnant patients
• Female patients in a phase of the menstrual cycle other than premenstrual, nausea and vomiting within 24 hours before anaesthesia
• Known allergy to anti-inflammatory drugs, opioids and ondansetron.
• Patients with a pre-existing chronic pain disorder or with a gastrointestinal disease.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Catholic University of the Sacred Heart

Overall Clinical Trial Officials and Contacts

Germano De Cosmo, MD Principal Investigator Catholic University of Sacred Heart  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00674713

Study ID Number: 1014/05

ClinicalTrials.gov Identifier: NCT00674713

Health Authority: Italy: Ethics Committee