Postoperative nausea and vomiting laparoscopic cholecistectomy MedDRA version: 9.1 Level: LLT Classification code 10008629 Term: Cholelithiasis
Conditions
Interventions
Trade Name: ZOFRAN*IM IV 1F 2ML 4MG
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ondansetron
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Italy
Outcome results
None listed