NCT04899817

Brief Summary

Study aims at comparing the effect of granisteron with that of metoclopramide in patients undergoing lab cholecystectomy

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
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2021

Shorter than P25 for phase_4

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

April 20, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

10 months

First QC Date

April 20, 2021

Last Update Submit

May 19, 2021

Conditions

Nausea and Vomiting, Postoperative

Keywords

Laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Postoperative nausea and vomitting

    Number of attacks of nausea and vomitting

    Every 2 hours for 12 hours

Study Arms (2)

Group G

ACTIVE COMPARATOR

will receive granisteron 1mg after induction of general anesthesia

Drug: Granisetron

Group C

PLACEBO COMPARATOR

Will receive metoclopramide 10 mg after induction of general anesthesia

Drug: Granisetron

Interventions

GranisetronDRUG

The drug is given after induction of general anesthesia

Also known as: Granitryl
Group CGroup G

Eligibility Criteria

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

You may qualify if:

  • both sexes Age between 18 and 60 years ASA1 2 3 Lap cholecystectomy under general anesthesia

You may not qualify if:

  • patients refusal Pregnancy and breastfeeding Hepatic or renal disease ASA4 5 Allergy to the drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Granisetron

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Azabicyclo CompoundsAza CompoundsOrganic ChemicalsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Eman M Esmail

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Layali Dardeer

CONTACT

01096928662as0296856@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

April 20, 2021

First Posted

May 25, 2021

Study Start

May 1, 2021

Primary Completion

March 1, 2022

Study Completion

April 1, 2022

Last Updated

May 25, 2021

Record last verified: 2021-05

Locations

EG(1)