Postoperative nausea and vomiting: acupuncture effect on postoperative prevention - ND

Conditions: MedDRA version: 9.1Level: LLTClassification code 10008629Term: Cholelithiasis
Postoperative nausea and vomiting laparoscopic cholecistectomy

Registration Number: EUCTR2008-002343-16-IT

Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

either gender (female patients only if they were in the premenstrual phase of the menstrual cycle), ASA I-II, age between 18 and 70 years, elective laparoscopic cholecistectomy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

patients refusal, pregnant women, acupuncure treatment in the last six months, history of carpal tunnel syndrome or eczema at P6 point, nausea and vomiting within 24 hours before anaesthesia, known allergy to anti-inflammatory drugs, opioids and ondansetron, pre-existing chronic pain disorder or gastrointestinal disease.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to investigate if P6 acuptuncture made after induction of general anaesthesia may be effective for the prevention of PONV as ondansetron and if the acupuncture-ondansetron combination may enhance single (acupuncture or ondansetron) therapy efficacy in patients undergoing laparoscopic cholecistectomy.;Secondary Objective: to investigate side effects of treatments in study;Primary end point(s): Incidence of postoperative nausea Verbal Rating Scale) and vomiting (number of episodes).

Secondary Outcome Measures