Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
- Conditions
- Postoperative Nausea and VomitingPostoperative Complications
- Interventions
- Drug: Group A - gabapentin 600 mgDrug: Group B - pregabalinDrug: Group C - placebo
- Registration Number
- NCT03202459
- Lead Sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Brief Summary
Postoperative nausea and vomiting (PONV) is one of the most commonly reported adverse effects of anesthesia. The general incidence of vomiting is approximately 30%, nausea at 50% and the PONV rate can go up to 80% in high-risk patients without prophylaxis. Prevention of these episodes in high-risk patients improves satisfaction and well-being rates. Therefore, it becomes important the adequate control of PONV, aiming at the satisfaction of the patient with the procedure, lower costs for the health system as well as reduction of complications in the postoperative period. This study aims to evaluate the association of gabapentin or pregabalin with dexamethasone in reducing the incidence of PONV in high-risk patients undergoing laparoscopic surgeries in the first 48 hours postoperatively as well as to assess side effects.
- Detailed Description
The study included 60 patients at high risk for PONV (Apfel-score 0, I, II, III and IV) scheduled for elective laparoscopic surgeries at the Central Surgical Center of Irmandade da Santa Casa de Misericórdia in São Paulo. Inclusion criteria will be ASA I or II of either sex, in the age range of 18 to 70 years. In this study, the recruited patients will be allocated randomly into three groups. The group A will receive oral 600 mg gabapentin 2 h before surgery. The group B will receive oral 150 mg pregabalin 2 h before surgery. The Group C will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery. This study is "double-blind", in which neither the doctor nor the patient knows what medicine is being given.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- Patients undergoing laparoscopic procedures
- Apfel Score 0, I, II, III and IV
- ASA I / II
- Patients with surgery converted to open before thirty minutes of surgery
- Patients who were exposed previously to gabapentin or pregabalin Patients who have allergy to any medicine used in the study
- Patient who have to any cognitive impairment
- Illiterate patients
- Patients who refuse to participate in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Comparator: Group A - gabapentin Group A - gabapentin 600 mg The patient will receive oral 600 mg gabapentin 2 h before surgery Active Comparator: Group B - pregabalin Group B - pregabalin The patient will receive oral pregabalin 150 mg 2 h before surgery Placebo Comparator: Group C - placebo Group C - placebo The patient will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery
- Primary Outcome Measures
Name Time Method Postoperative Nausea or vomiting M12 12 hours The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 12 hours after surgery
Postoperative Nausea or vomiting M48 48 hours The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 48 hours after surgery
Postoperative Nausea or vomiting M24 24 hours The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 24 hours after surgery
Postoperative Nausea or vomiting M0 1 hours The occurrence of postoperative nausea or vomiting, in the recovery room, during the first hour after surgery
- Secondary Outcome Measures
Name Time Method Patient demographic data Before surgery With a questionnaire will be studied the variables: age, sex, weight, height, BMI
Duration of postoperative anesthesia stay First hours after surgery Time to postoperative anesthesia care unit discharge alive (hours)
Amount of medication During the first 30 days after surgery Reported by a healthcare provider
Postoperative complications During the first 30 days after surgery Postoperative complications after surgery
Degree of patient satisfaction Before discharge The patient's overall satisfaction will be assessed using point scales (very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied)
The length of stay in hospital From end of surgery until hospital discharge or 30 days after surgery Time of stay in hospital
Time to request the first medication for nausea and vomiting First hour after surgery Reported by the patient or by a healthcare provider
Surgical Duration First hour after surgery Time of surgery
Trial Locations
- Locations (1)
Irmandade da Santa Casa de Misericórdia de São Paulo
🇧🇷São Paulo, Brazil