Effect of Acupuncture on Postoperative Nausea and Vomiting

Cholelithiasis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674713
• Other study ID #: 1014/05
• Status: Completed
• Phase: Phase 4
• First received: May 5, 2008
• Last updated: May 7, 2008
• Start date: January 2006
• Est. completion date: September 2007

Study information

• Verified date: May 2008
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Postoperative Nausea and Vomiting

Intervention

Other:
• Acupuncture

Drug:
• Ondansetron

• Physiological saline solution

Other:
• Sham acupuncture

Drug:
• Ondansetron

Other:
• Acupuncture at P6 point

Drug:
• Physiological saline solution

Other:
• Sham acupuncture

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative nausea and vomiting		24 postoperative hours	No