Effect of Acupuncture on Postoperative Nausea and Vomiting

Phase 4

Completed

• Conditions: Cholelithiasis
• Interventions: Other: Acupuncture; Drug: Ondansetron; Drug: Physiological saline solution; Other: Sham acupuncture; Other: Acupuncture at P6 point

• Registration Number: NCT00674713
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2008-05
• Study First Submitted: 2008-05-05
• Study First Submitted QC: 2008-05-07
• Last Update Submitted: 2008-05-07
• Study First Posted: 2008-05-08
• Last Update Posted: 2008-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Acupuncture	Patients receiving acupuncture at P6 point plus physiological saline solution
A	Physiological saline solution	Patients receiving acupuncture at P6 point plus physiological saline solution
B	Ondansetron	Patients receiving ondansetron plus sham acupuncture
B	Sham acupuncture	Patients receiving ondansetron plus sham acupuncture
C	Ondansetron	Patients receiving ondansetron plus acupuncture at P6 point
C	Acupuncture at P6 point	Patients receiving ondansetron plus acupuncture at P6 point
D	Physiological saline solution	Patients receiving physiological saline solution plus sham acupuncture
D	Sham acupuncture	Patients receiving physiological saline solution plus sham acupuncture

Primary Outcome Measures

Name	Time	Method
postoperative nausea and vomiting	24 postoperative hours

Trial Locations

Locations (1)

Catholic University of Sacred Heart; 🇮🇹 Rome, Italy