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Effect of Acupuncture on Postoperative Nausea and Vomiting

NCT ID: NCT00674713

Last Updated: 2008-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cholelithiasis

Keywords

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Patients undergoing laparoscopic cholecystectomy for cholelithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A

Patients receiving acupuncture at P6 point plus physiological saline solution

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

Physiological saline solution

Intervention Type DRUG

B

Patients receiving ondansetron plus sham acupuncture

Group Type ACTIVE_COMPARATOR

Ondansetron

Intervention Type DRUG

Sham acupuncture

Intervention Type OTHER

C

Patients receiving ondansetron plus acupuncture at P6 point

Group Type OTHER

Ondansetron

Intervention Type DRUG

Acupuncture at P6 point

Intervention Type OTHER

D

Patients receiving physiological saline solution plus sham acupuncture

Group Type PLACEBO_COMPARATOR

Physiological saline solution

Intervention Type DRUG

Sham acupuncture

Intervention Type OTHER

Interventions

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Acupuncture

Intervention Type OTHER

Ondansetron

Intervention Type DRUG

Physiological saline solution

Intervention Type DRUG

Sham acupuncture

Intervention Type OTHER

Ondansetron

Intervention Type DRUG

Acupuncture at P6 point

Intervention Type OTHER

Physiological saline solution

Intervention Type DRUG

Sham acupuncture

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Principal Investigators

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Germano De Cosmo, MD

Role: PRINCIPAL_INVESTIGATOR

Catholic University of Sacred Heart

Locations

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Catholic University of Sacred Heart

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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1014/05

Identifier Type: -

Identifier Source: org_study_id