PONV
Conditions
Keywords
PONV, Palonosetron, Ondansetron, Cesarean section
Brief summary
This study aims to compare the quality of perioperative antiemesis of palonosetron and ondansetron in patients undergoing cesarean section
Detailed description
Perioperative nausea and vomiting (PONV) related to spinal block anesthesia are common events and unpleasant for pregnant women. Its incidence can reach 80% in high-risk patients, and remains high despite the emergence of new antiemetic drugs. Episodes untreated can result in prolonged stay in post-anesthetic care unit (PACU) and rehospitalization which can result in significant increase in overall costs of health care. The purpose of the prophylaxis of PONV is therefore decrease its incidence, the stress of the patient, improve the quality and safety of surgical procedure and reduce hospital costs. Antagonists of the 5-hydroxytryptamine 3 subtype receptor have been widely used and effective against PONV due to its efficacy and a favorable side-effect profile. Palonosetron is a new and potent drug generation5 second-HT antagonist with improved profile that acts longer. Recent studies where it was compared to ondansetron and palonosetron in high-risk patients in head and neck surgery and laparoscopic surgery is disclosed palonosetron far superior to ondansetron especially 2-24 hours after surgery. But there are no studies on caesareans comparing the two drugs. This prospective, randomized, double-blind, placebo controlled, was designed to evaluate the efficacy of palonosetron compared with ondansetron and placebo for the prevention of nausea and vomiting in patients undergoing cesarean delivery under spinal anesthesia.
Interventions
DRUGPlacebo
Patients will receive regular spinal anesthesia
DRUGOndansetron
Patients will receive slow intravenous injection of ondansetron 4 mg after cord clamping
DRUGPalonosetron
Patients will receive slow intravenous infection of palonosetron 75 mcg after cord clamping
Sponsors
Hospital de Base
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists class I or II * Scheduled for cesarean section on Maternal and Child Hospital of Brasilia, Federal District, Brazil
Exclusion criteria
* patients who had received antiemetics, diabetic, allergic to any study drug, corticosteroid use, psychoactive drugs, patients with vomiting in the course of gastrointestinal disease, eclampsia, heart disease, smokers, any evidence of fetal distress, psychiatric disease or who refused to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with nausea and vomiting | Within the first 48 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nausea Scores on the Number Rating Scale | Within the first 48 hours after surgery | Quantify nausea by Number Rating Scale (NRS, ranging from 0 to 10 cm, zero being found when the patient is no nausea and ten, with maximum or un bearable nausea |
| Nausea Scores on the Verbal Rating Scale | Within the first 48 hours after surgery | Verbal Rating Scale (VRS), consisting of a list of phrases (no nausea, mild nausea, moderate nausea, intense nausea, maximum nausea) |
| Apgar Newborn | delivery | The resulting Apgar score ranges from zero to 10, measured at first and fifth minute |
| Likert Scale | 48 hours after surgery | Overall satisfaction with the nausea - vomiting experience in a Likert scale of four points (dissatisfied, neutral, satisfied and very satisfied) |
| Number of participants with adverse events as a measure of safety and tolerability | delivery | Intraoperative hemodynamic stability analysis through the incidence of tachycardia, hypertension, bradycardia, hypotension and consumed vasopressors |
Countries
Brazil
Outcome results
None listed