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

Sponsored by:	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

MedlinePlus related topics: Acupuncture Gallstones Nausea and Vomiting

Drug Information available for: Ondansetron hydrochloride Ondansetron

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment

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
A: Experimental Patients receiving acupuncture at P6 point plus physiological saline solution	Other: Acupuncture Drug: Physiological saline solution
B: Active Comparator 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
D: Placebo Comparator 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 )
Study ID Numbers:	1014/05
Study First Received:	May 5, 2008
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00674713 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by Catholic University of the Sacred Heart:

Patients undergoing laparoscopic cholecystectomy for cholelithiasis

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Gallbladder Diseases
Cholecystolithiasis
Neurotransmitter Agents
Vomiting
Signs and Symptoms, Digestive
Psychotropic Drugs
Antiemetics
Calculi
Signs and Symptoms
Biliary Tract Diseases
Antipruritics
Nausea

Ondansetron
Postoperative Nausea and Vomiting
Cholelithiasis
Tranquilizing Agents
Gallstones
Central Nervous System Depressants
Antipsychotic Agents
Serotonin
Digestive System Diseases
Postoperative Complications
Anti-Anxiety Agents
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Gallbladder Diseases
Cholecystolithiasis
Neurotransmitter Agents
Vomiting
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Calculi
Signs and Symptoms
Serotonin Antagonists
Pathologic Processes
Biliary Tract Diseases

Therapeutic Uses
Antipruritics
Nausea
Ondansetron
Dermatologic Agents
Postoperative Nausea and Vomiting
Tranquilizing Agents
Cholelithiasis
Gallstones
Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
Serotonin Agents
Digestive System Diseases

ClinicalTrials.gov processed this record on May 07, 2009