Effect of Acupuncture on Postoperative Nausea and Vomiting

May 7, 2008 updated by: Catholic University of the Sacred Heart
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Catholic University Of Sacred Heart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Patients receiving acupuncture at P6 point plus physiological saline solution
Other: Acupuncture
Drug: Physiological saline solution
Active Comparator: B
Patients receiving ondansetron plus sham acupuncture
Other: Sham acupuncture
Drug: Ondansetron
Other: C
Patients receiving ondansetron plus acupuncture at P6 point
Drug: Ondansetron
Other: Acupuncture at P6 point
Placebo Comparator: D
Patients receiving physiological saline solution plus sham acupuncture
Other: Sham acupuncture
Drug: Physiological saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative nausea and vomiting
Time Frame: 24 postoperative hours
24 postoperative hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Investigators

  • Principal Investigator: Germano De Cosmo, MD, Catholic University Of Sacred Heart

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

May 5, 2008

First Submitted That Met QC Criteria

May 7, 2008

First Posted (Estimate)

May 8, 2008

Study Record Updates

Last Update Posted (Estimate)

May 8, 2008

Last Update Submitted That Met QC Criteria

May 7, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1014/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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