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Effect of Acupuncture on Postoperative Nausea and Vomiting

Primary Purpose

Cholelithiasis

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Acupuncture
Ondansetron
Physiological saline solution
Sham acupuncture
Ondansetron
Acupuncture at P6 point
Physiological saline solution
Sham acupuncture
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholelithiasis focused on measuring Patients undergoing laparoscopic cholecystectomy for cholelithiasis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Catholic University of Sacred Heart

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Other

Placebo Comparator

Arm Label

A

B

C

D

Arm Description

Patients receiving acupuncture at P6 point plus physiological saline solution

Patients receiving ondansetron plus sham acupuncture

Patients receiving ondansetron plus acupuncture at P6 point

Patients receiving physiological saline solution plus sham acupuncture

Outcomes

Primary Outcome Measures

postoperative nausea and vomiting

Secondary Outcome Measures

Full Information

First Posted
May 5, 2008
Last Updated
May 7, 2008
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT00674713
Brief Title
Effect of Acupuncture on Postoperative Nausea and Vomiting
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis
Keywords
Patients undergoing laparoscopic cholecystectomy for cholelithiasis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Patients receiving acupuncture at P6 point plus physiological saline solution
Arm Title
B
Arm Type
Active Comparator
Arm Description
Patients receiving ondansetron plus sham acupuncture
Arm Title
C
Arm Type
Other
Arm Description
Patients receiving ondansetron plus acupuncture at P6 point
Arm Title
D
Arm Type
Placebo Comparator
Arm Description
Patients receiving physiological saline solution plus sham acupuncture
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Type
Drug
Intervention Name(s)
Physiological saline solution
Intervention Type
Other
Intervention Name(s)
Sham acupuncture
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Type
Other
Intervention Name(s)
Acupuncture at P6 point
Intervention Type
Drug
Intervention Name(s)
Physiological saline solution
Intervention Type
Other
Intervention Name(s)
Sham acupuncture
Primary Outcome Measure Information:
Title
postoperative nausea and vomiting
Time Frame
24 postoperative hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Germano De Cosmo, MD
Organizational Affiliation
Catholic University of Sacred Heart
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic University of Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

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Effect of Acupuncture on Postoperative Nausea and Vomiting

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