NCT02468323

Brief Summary

This study aims to compare the quality of perioperative antiemesis of palonosetron and ondansetron in patients undergoing cesarean section

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

June 7, 2015

Last Update Submit

March 8, 2017

Conditions

PONV

Keywords

PONVPalonosetronOndansetronCesarean section

Outcome Measures

Primary Outcomes (1)

  • Number of participants with nausea and vomiting

    Within the first 48 hours after surgery

Secondary Outcomes (6)

  • Nausea Scores on the Number Rating Scale

    Within the first 48 hours after surgery

  • Nausea Scores on the Verbal Rating Scale

    Within the first 48 hours after surgery

  • Apgar Newborn

    delivery

  • Likert Scale

    48 hours after surgery

  • Number of participants with adverse events as a measure of safety and tolerability

    delivery

  • +1 more secondary outcomes

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

Patients in placebo group will receive spinal anesthesia with bupivacaine and morphine and a slow intravenous injection of saline 0,9%.

Drug: OndansetronDrug: Palonosetron

Ondansetron group

EXPERIMENTAL

Patients in placebo group will receive spinal anesthesia with bupivacaine and morphine and a slow intravenous injection of ondansetron after cord clamping.

Drug: PlaceboDrug: Palonosetron

Palonosetron group

EXPERIMENTAL

Patients in placebo group will receive spinal anesthesia with bupivacaine and morphine and a slow intravenous injection of palonosetron after cord clamping.

Drug: PlaceboDrug: Ondansetron

Interventions

PlaceboDRUG

Patients will receive regular spinal anesthesia

Also known as: Saline
Ondansetron groupPalonosetron group
OndansetronDRUG

Patients will receive slow intravenous injection of ondansetron 4 mg after cord clamping

Palonosetron groupPlacebo group
PalonosetronDRUG

Patients will receive slow intravenous infection of palonosetron 75 mcg after cord clamping

Ondansetron groupPlacebo group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists class I or II
  • Scheduled for cesarean section on Maternal and Child Hospital of Brasilia, Federal District, Brazil

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Base do Distrito Federal

Brasília, Federal District, 70680250, Brazil

Location

Related Publications (1)

  • 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. Epub 2014 Oct 7.

    PMID: 25737619BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Sodium ChlorideOndansetronPalonosetron

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingQuinuclidinesHeterocyclic Compounds, Bridged-RingIsoquinolines

Study Officials

  • Fabricio T Mendonca, MD, TSA

    Hospital de Base do Distrito Federal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, TSA

Study Record Dates

First Submitted

June 7, 2015

First Posted

June 10, 2015

Study Start

October 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 9, 2017

Record last verified: 2017-03

Locations

BR(1)