Effect of Acupuncture on Postoperative Nausea and Vomiting

Catholic University of the Sacred Heart

Status and phase: Completed; Phase 4

Conditions: Cholelithiasis

Treatments: Other: Acupuncture; Other: Sham acupuncture; Other: Acupuncture at P6 point; Drug: Ondansetron; Drug: Physiological saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT00674713

1014/05

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 4 patient groups, including a placebo group

A

Experimental group

Description:

Patients receiving acupuncture at P6 point plus physiological saline solution

Treatment:

Other: Acupuncture

Drug: Physiological saline solution

Drug: Physiological saline solution

B

Active Comparator group

Description:

Patients receiving ondansetron plus sham acupuncture

Treatment:

Other: Sham acupuncture

Other: Sham acupuncture

Drug: Ondansetron

Drug: Ondansetron

C

Other group

Description:

Patients receiving ondansetron plus acupuncture at P6 point

Treatment:

Other: Acupuncture at P6 point

Drug: Ondansetron

Drug: Ondansetron

D

Placebo Comparator group

Description:

Patients receiving physiological saline solution plus sham acupuncture

Treatment:

Other: Sham acupuncture

Other: Sham acupuncture

Drug: Physiological saline solution

Drug: Physiological saline solution