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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

Page last updated: June 20, 2008

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