Postoperative Complications, Postoperative Nausea and Vomiting
Conditions
Keywords
Anesthesia, Complications, Nausea, Vomiting
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.
Interventions
DRUGGroup A - gabapentin 600 mg
The patient will receive oral 600 mg gabapentin 2 h before surgery
DRUGGroup B - pregabalin
The patient will receive oral pregabalin 150 mg 2 h before surgery
The patient will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery
Sponsors
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing laparoscopic procedures * Apfel Score 0, I, II, III and IV * ASA I / II
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Nausea or vomiting M0 | 1 hours | The occurrence of postoperative nausea or vomiting, in the recovery room, during the first hour after surgery |
| 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 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to request the first medication for nausea and vomiting | First hour after surgery | Reported by the patient or by a healthcare provider |
| Amount of medication | During the first 30 days after surgery | Reported by a healthcare provider |
| Patient demographic data | Before surgery | With a questionnaire will be studied the variables: age, sex, weight, height, BMI |
| 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) |
| Postoperative complications | During the first 30 days after surgery | Postoperative complications after surgery |
| Surgical Duration | First hour after surgery | Time of surgery |
| Duration of postoperative anesthesia stay | First hours after surgery | Time to postoperative anesthesia care unit discharge alive (hours) |
| The length of stay in hospital | From end of surgery until hospital discharge or 30 days after surgery | Time of stay in hospital |
Countries
Brazil
Contacts
Primary ContactLigia Andrade da Silva Telles Mathias, Doctor
Backup ContactThiago Grigio, Master
Outcome results
None listed