NCT00674713

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2008

Completed
Last Updated

May 8, 2008

Status Verified

May 1, 2008

Enrollment Period

1.7 years

First QC Date

May 5, 2008

Last Update Submit

May 7, 2008

Conditions

Cholelithiasis

Keywords

Patients undergoing laparoscopic cholecystectomy for cholelithiasis

Outcome Measures

Primary Outcomes (1)

  • postoperative nausea and vomiting

    24 postoperative hours

Study Arms (4)

A

EXPERIMENTAL

Patients receiving acupuncture at P6 point plus physiological saline solution

Other: AcupunctureDrug: Physiological saline solution

B

ACTIVE COMPARATOR

Patients receiving ondansetron plus sham acupuncture

Drug: OndansetronOther: Sham acupuncture

C

OTHER

Patients receiving ondansetron plus acupuncture at P6 point

Drug: OndansetronOther: Acupuncture at P6 point

D

PLACEBO COMPARATOR

Patients receiving physiological saline solution plus sham acupuncture

Drug: Physiological saline solutionOther: Sham acupuncture

Interventions

AcupunctureOTHER
A
OndansetronDRUG
B
Physiological saline solutionDRUG
A
Sham acupunctureOTHER
B
Acupuncture at P6 pointOTHER
C

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ASA I-II scheduled for elective laparoscopic cholecystectomy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Sacred Heart

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Cholelithiasis

Interventions

Acupuncture TherapyOndansetron

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Germano De Cosmo, MD

    Catholic University of Sacred Heart

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 5, 2008

First Posted

May 8, 2008

Study Start

January 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

May 8, 2008

Record last verified: 2008-05

Locations

IT(1)