NCT03586817

Brief Summary

Cholelithiasis (presence of gallbladder stones) is prevalent in 10 to 15% of the world population. This disease can lead to serious complications such as cholecystitis, cholangitis and pancreatitis. Video-laparoscopic cholecystectomy (CVL) is considered the gold standard treatment of this condition. Despite ongoing research and development of new drugs and techniques, postoperative nausea and vomiting (PONV) are frequent, lead to unexpected hospitalizations, delay hospital discharge, increase hospital costs, and cause patient dissatisfaction. Video-laparoscopic surgeries are cited in the literature as a risk factor for PONV, with an incidence of up to 75% in cases where prophylactic drugs are not used.Through the simplified Apfel score, it is possible to determine the risk for PONV. This risk classification is based on four risk factors: female gender, non-smoking, postoperative use of opioids and previous history of PONV. The incidence of PONV would be 10%, 20%, 40%, 60% and 80%, respectively, if none, one, two, three or four risk factors are present. Antiemetics recommended for prophylaxis of PONV in adults include 5-hydroxytryptamine (5-HT3) receptor antagonists (ondansetron, dolasetron, granisetron, tropisetron, ramosetron and palonosetron), neurokinin-1 (NK-1) receptor antagonists (aprepitant), (dendrohydrin and haloperidol), antihistamines (dimenhydrin and meclizine), and anticholinergics (scopolamine).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 16, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

March 2, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2019

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

Same day

First QC Date

June 29, 2018

Last Update Submit

March 10, 2019

Conditions

Nausea and Vomiting, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Number of complete responder

    individuals without nausea or vomiting

    48 hours

Secondary Outcomes (2)

  • Nausea

    the first postoperative 48 hours

  • vomiting

    the first postoperative 48 hours

Study Arms (2)

Palonosetrona

ACTIVE COMPARATOR

Palonosetron 75 mcg during the anesthesia

Drug: Palonosetron

Fosaprepitant

ACTIVE COMPARATOR

Fosaprepitant 150 mg during the anesthesia

Drug: Fosaprepitant

Interventions

PalonosetronDRUG

75 mcg during the anesthesia

Palonosetrona
FosaprepitantDRUG

150 mg during the anesthesia

Fosaprepitant

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFenale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women
  • Non fumant
  • cholelitiasis

You may not qualify if:

  • severe heart, pulmonay, renal or liver diseases
  • Tabagism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Federal de Bonsucesso

Rio de Janeiro, 21041-030, Brazil

RECRUITING

Related Publications (5)

  • Stinton LM, Shaffer EA. Epidemiology of gallbladder disease: cholelithiasis and cancer. Gut Liver. 2012 Apr;6(2):172-87. doi: 10.5009/gnl.2012.6.2.172. Epub 2012 Apr 17.

    PMID: 22570746BACKGROUND

  • Chandrakantan A, Glass PS. Multimodal therapies for postoperative nausea and vomiting, and pain. Br J Anaesth. 2011 Dec;107 Suppl 1:i27-40. doi: 10.1093/bja/aer358.

    PMID: 22156268BACKGROUND

  • Apfel CC, Roewer N. Risk assessment of postoperative nausea and vomiting. Int Anesthesiol Clin. 2003 Fall;41(4):13-32. doi: 10.1097/00004311-200341040-00004. No abstract available.

    PMID: 14574212BACKGROUND

  • Muchatuta NA, Paech MJ. Management of postoperative nausea and vomiting: focus on palonosetron. Ther Clin Risk Manag. 2009 Feb;5(1):21-34. Epub 2009 Mar 26.

    PMID: 19436621BACKGROUND

  • Singh PM, Borle A, Rewari V, Makkar JK, Trikha A, Sinha AC, Goudra B. Aprepitant for postoperative nausea and vomiting: a systematic review and meta-analysis. Postgrad Med J. 2016 Feb;92(1084):87-98. doi: 10.1136/postgradmedj-2015-133515. Epub 2015 Dec 1.

    PMID: 26627976BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Palonosetronfosaprepitant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

QuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 29, 2018

First Posted

July 16, 2018

Study Start

March 2, 2019

Primary Completion

March 2, 2019

Study Completion

December 1, 2020

Last Updated

March 12, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)