PONV Clinical Trial
— PONVOfficial title:
Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for Cesarean Sections Under Regional Anesthesia: Study Single Center, Prospective, Double-blind, Randomized, Placebo Controlled
Verified date | March 2017 |
Source | Hospital de Base |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to compare the quality of perioperative antiemesis of palonosetron and ondansetron in patients undergoing cesarean section
Status | Completed |
Enrollment | 150 |
Est. completion date | February 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Base do Distrito Federal | Brasilia | DF |
Lead Sponsor | Collaborator |
---|---|
Hospital de Base |
Brazil,
Chattopadhyay S, Goswami S. Palonosetron Versus Ramosetron Prophylaxis for Control of Postoperative Nausea and Vomiting after Cesarean Delivery under Spinal Anesthesia. J Obstet Gynaecol India. 2015 Feb;65(1):28-33. doi: 10.1007/s13224-014-0612-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with nausea and vomiting | Within the first 48 hours after surgery | ||
Secondary | 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 | Within the first 48 hours after surgery | |
Secondary | 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) | Within the first 48 hours after surgery | |
Secondary | Apgar Newborn | The resulting Apgar score ranges from zero to 10, measured at first and fifth minute | delivery | |
Secondary | Likert Scale | Overall satisfaction with the nausea - vomiting experience in a Likert scale of four points (dissatisfied, neutral, satisfied and very satisfied) | 48 hours after surgery | |
Secondary | 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 | delivery | |
Secondary | 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 | Within the first 48 hours after surgery |
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