A Phase 4 interventional study of Placebo and Ondansetron in PONV, sponsored by Hospital de Base. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-03-09.
Sponsored by Hospital de Base · Phase 4, Interventional, and Prevention
This study aims to compare the quality of perioperative antiemesis of palonosetron and ondansetron in patients undergoing cesarean section
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.
Hospital de Base is the lead sponsor of 24 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in placebo group will receive spinal anesthesia with bupivacaine and morphine and a slow intravenous injection of saline 0,9%.
Drug: Ondansetron · Drug: Palonosetron
Patients in placebo group will receive spinal anesthesia with bupivacaine and morphine and a slow intravenous injection of ondansetron after cord clamping.
Drug: Placebo · Drug: Palonosetron
Patients in placebo group will receive spinal anesthesia with bupivacaine and morphine and a slow intravenous injection of palonosetron after cord clamping.
Drug: Placebo · Drug: Ondansetron
Patients will receive regular spinal anesthesia
Also known as: Saline
Patients will receive slow intravenous injection of ondansetron 4 mg after cord clamping
Patients will receive slow intravenous infection of palonosetron 75 mcg after cord clamping
Number of participants with nausea and vomiting
Time frame: Within the first 48 hours after surgery
Nausea Scores on the Number Rating Scale
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
Time frame: Within the first 48 hours after surgery
Nausea Scores on the Verbal Rating Scale
Verbal Rating Scale (VRS), consisting of a list of phrases (no nausea, mild nausea, moderate nausea, intense nausea, maximum nausea)
Time frame: Within the first 48 hours after surgery
Apgar Newborn
The resulting Apgar score ranges from zero to 10, measured at first and fifth minute
Time frame: delivery
Likert Scale
Overall satisfaction with the nausea - vomiting experience in a Likert scale of four points (dissatisfied, neutral, satisfied and very satisfied)
Time frame: 48 hours after surgery
Number of participants with adverse events as a measure of safety and tolerability
Intraoperative hemodynamic stability analysis through the incidence of tachycardia, hypertension, bradycardia, hypotension and consumed vasopressors
Time frame: delivery
Number of participants with adverse events as a measure of safety and tolerability
Incidence of adverse effects such as nausea, vomiting, pruritus, urinary retention, drowsiness and consumed rescue antiemetics
Time frame: Within the first 48 hours after surgery
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Hospital de Base