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Effect of Acupuncture on Postoperative Nausea and Vomiting

This study has been completed.
Sponsor:
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT00674713
First received: May 5, 2008
Last updated: May 7, 2008
Last verified: May 2008
History of Changes

May 5, 2008
May 7, 2008
January 2006
September 2007   (final data collection date for primary outcome measure)
postoperative nausea and vomiting [ Time Frame: 24 postoperative hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00674713 on ClinicalTrials.gov Archive Site
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Effect of Acupuncture on Postoperative Nausea and Vomiting
Not Provided

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cholelithiasis
  • Other: Acupuncture
  • Drug: Ondansetron
  • Drug: Physiological saline solution
  • Other: Sham acupuncture
  • Other: Acupuncture at P6 point
  • Experimental: A
    Patients receiving acupuncture at P6 point plus physiological saline solution
    Interventions:
    • Other: Acupuncture
    • Drug: Physiological saline solution
  • Active Comparator: B
    Patients receiving ondansetron plus sham acupuncture
    Interventions:
    • Drug: Ondansetron
    • Other: Sham acupuncture
  • C
    Patients receiving ondansetron plus acupuncture at P6 point
    Interventions:
    • Drug: Ondansetron
    • Other: Acupuncture at P6 point
  • Placebo Comparator: D
    Patients receiving physiological saline solution plus sham acupuncture
    Interventions:
    • Drug: Physiological saline solution
    • Other: Sham acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
September 2007
September 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00674713
1014/05
Not Provided
Germano De Cosmo
Catholic University of the Sacred Heart
Not Provided
Principal Investigator: Germano De Cosmo, MD Catholic University of Sacred Heart
Catholic University of the Sacred Heart
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP