Effect of Acupuncture on Postoperative Nausea and Vomiting - Full Text View

Sponsor:	Catholic University of the Sacred Heart
Information provided by:	Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:	NCT00674713

Purpose

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.

Condition	Intervention	Phase
Cholelithiasis	Other: Acupuncture Drug: Ondansetron Drug: Physiological saline solution Other: Sham acupuncture Other: Acupuncture at P6 point	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Acute Bronchitis Gallstones Nausea and Vomiting

Drug Information available for: Ondansetron hydrochloride Ondansetron

U.S. FDA Resources

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:

postoperative nausea and vomiting [ Time Frame: 24 postoperative hours ] [ Designated as safety issue: No ]

Enrollment:	140
Study Start Date:	January 2006
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	Drug: Ondansetron Other: Sham acupuncture
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	Drug: Physiological saline solution Other: Sham acupuncture

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674713

Locations

Italy
Catholic University of Sacred Heart
Rome, Italy, 00168

Sponsors and Collaborators

Catholic University of the Sacred Heart

Investigators

Principal Investigator:

Germano De Cosmo, MD

Catholic University of Sacred Heart

More Information

No publications provided

Responsible Party:	Germano De Cosmo
ClinicalTrials.gov Identifier:	NCT00674713 History of Changes
Other Study ID Numbers:	1014/05
Study First Received:	May 5, 2008
Last Updated:	May 7, 2008
Health Authority:	Italy: Ethics Committee

Keywords provided by Catholic University of the Sacred Heart:

Patients undergoing laparoscopic cholecystectomy for cholelithiasis

Additional relevant MeSH terms:

Cholelithiasis
Cholecystolithiasis
Gallstones
Postoperative Nausea and Vomiting
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Vomiting

Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012