Effect of Acupuncture on Postoperative Nausea and Vomiting
Information source: Catholic University of the Sacred Heart
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cholelithiasis
Intervention: Acupuncture (Other); Ondansetron (Drug); Physiological saline solution (Drug); Sham acupuncture (Other); Acupuncture at P6 point (Other)
Phase: Phase 4
Status: Completed
Sponsored by: Catholic University of the Sacred Heart Official(s) and/or principal investigator(s):
Germano De Cosmo, MD, Principal Investigator, Affiliation: Catholic University of Sacred Heart
Summary
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.
Clinical Details
Study design: Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment
Primary outcome: postoperative nausea and vomiting
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Catholic University of Sacred Heart, Rome 00168, Italy
Additional Information
Starting date: January 2006
Ending date: September 2007
Last updated: May 7, 2008
|
