NCT04576390

Brief Summary

This study is designed to compare the effects of a single dose Ondansetron 4mg versus Palonosetron 75mcg in the prophylaxis against early \& delayed postoperative nausea and vomiting in the first 48 hours post-operatively in patients undergoing Endoscopic Retrograde Cholangio-Pancreatography (ERCP) to determine the complete response, complete control and failure rates.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_4

Status
unknown

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

September 23, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 6, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

October 24, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2021

Completed
Last Updated

October 6, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

September 23, 2020

Last Update Submit

September 29, 2020

Conditions

AntiemeticPostoperative Nausea and Vomiting

Keywords

PalonosetronOndansetronPONVERCP

Outcome Measures

Primary Outcomes (1)

  • Incidence of PONV

    Incidence of nausea, retching or vomiting

    During 24 hours post-operatively

Secondary Outcomes (5)

  • Incidence of PONV

    During 48 hours post-operatively

  • Complete Responders

    During 48 hours postoperatively

  • Complete control

    During 48 hours postoperatively

  • Failed prophylaxis

    During 48 hours postoperatively

  • Time to rescue anti-emetics or emesis

    Time in minutes during 48 hours postoperatively

Study Arms (2)

Group O

ACTIVE COMPARATOR

On the day of procedure, the recruited patients in Group O will be given Ondansetron 4 mg diluted for up to 5ml using normal saline by a colleague not participating to the study or the patient care \& will label the syringes as antiemetic.

Drug: Ondansetron 4 mg

Group P

ACTIVE COMPARATOR

On the day of procedure, the recruited patients in Group P will be given Palonosetron 75 mcg diluted for up to 5ml using normal saline by a colleague not participating to the study or the patient care \& will label the syringes as antiemetic.

Drug: Palonosetron 75 mcg

Interventions

Ondansetron 4 mgDRUG

Antiemetic drug

Also known as: Zofran
Group O
Palonosetron 75 mcgDRUG

Antiemetic drug

Also known as: Aloxi
Group P

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18-60 years of age
  • American Society of Anaesthesiologists physical status (ASA) grade I-II
  • Risk factor for PONV according to Apfel Score
  • o Apfel Score includes 4 points : Female gender, history of PONV and/or motion sickness, non-smoking status, and post-operative use of opioids , the risk of PONV is 10%, 20%, 40%,60% or 80% respectively
  • Undergoing elective ERCP.
  • Having provided written informed consent signed by patient or guardian.

You may not qualify if:

  • Allergy to any drug being used in the study
  • ASA III-IV
  • History of vomiting, retching, nausea or antiemetics use in the 24 hours prior to day of procedure
  • Patients receiving steroids, prokinetics, or antacids intake in the previous 48 hours
  • Patients with significant gastro-oesophageal disease
  • Menstruating, lactating or pregnant females
  • History of alcohol or substance abuse
  • Significant systemic disease of the liver, kidneys, heart, lungs, Cancer and or diabetes mellitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

OndansetronPalonosetron

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingQuinuclidinesHeterocyclic Compounds, Bridged-RingIsoquinolines

Study Officials

  • Omar M. Abou-Hashim, residant

    Theodor Bilharz Research Institute

    STUDY CHAIR

  • Yahia M. Hammad, Lecteurer

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Mounis A. Sedira, Prof.

CONTACT

00201110081661mounis200@yahoo.com

Ahmed M. Elbadawy, Prof.

CONTACT

00201005620903badawykhalil@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor doctor

Study Record Dates

First Submitted

September 23, 2020

First Posted

October 6, 2020

Study Start

October 24, 2020

Primary Completion

April 30, 2021

Study Completion

May 25, 2021

Last Updated

October 6, 2020

Record last verified: 2020-09