1. Home
  2. Approved trials
  3. » فارسی

Evalution of the granisetron instead of ondansetron

Protocol summary

Study aim
Determining the effect of granistrone instead of ondansetron on patients referred to the emergency room with nausea and vomiting
Design
A clinical trial in parallel, randomized, phase 3 on 100 patients. For randomization, the 4-way random block permutation method was used.
Settings and conduct
This study is a clinical trial in which people are divided into two groups completely randomly based on the 4-way random block permutation method and the study is conducted in a double-blind manner. Additional medicine is not injected to the patient and there is no disruption in the process of diagnosing and treating patients. Patients are treated for their disease and with the help of ondansetron and granistrone, their nausea and vomiting are controlled and the complications of vomiting are prevented.
Participants/Inclusion and exclusion criteria
The criteria for inclusion in the study were all patients who referred to the emergency department with complaints of nausea and vomiting and gave informed consent to participate in the study.Patients have nausea and vomiting with symptoms such as headache, lateralized symptoms, unstable vital signs.The patient has chest pain.Patients with Rise ICP symptoms or patients who have used drugs that increase serotonin in the last few days, such as fluoxetine, doxepin, isomerbuxazid, emitriptyline and or drugs that stimulate the liver cytochrome p450 enzyme, such as rifampin and anticonvulsant drugs, or drugs that inhibit liver enzymes such as cimetidine, ciprofloxacin, varithromycin, fluoxetine, deltiazom, and fluconazole.Patients who have consumed grapefruit in the last 24 hours.
Intervention groups
The first group is a vial of granistrone with 1 cc of distilled water and the second group is a vial of ondansetron, use VSA which is scored from 1 to 10 in 15, 30, 45, 60, 75, 90 minutes.
Main outcome variables
Severity nausea and vomiting

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230726058930N3
Registration date: 2024-01-20, 1402/10/30
Registration timing: prospective

Last update: 2024-01-20, 1402/10/30
Update count: 0
Registration date
2024-01-20, 1402/10/30
Registrant information
Name
Ali Vefagh Nematollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3367 5436
Email address
vefagh.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-01, 1402/11/12
Expected recruitment end date
2024-03-29, 1403/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evalution of the granisetron instead of ondansetron
Public title
Evalution of the granisetron instead of ondansetron in the emergency room
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Nausea Vomit
Exclusion criteria:
Patients with symptoms such as headaches, lateralized symptoms, and unstable vital signs. Patients who have chest pain or ECG changes. Patients with symptoms of Rise ICP. Patients who have used drugs that increase serotonin (such as fluoxetine, doxepin, isomerbuxazid, amitriptyline, etc.) in the last few days. Patients who have used drugs that increase serotonin (such as fluoxetine, doxepin, isomerbuxazid, amitriptyline, etc.) in the last few days. Patients who have consumed grapefruit in the past 24 hours Patient does not consent to attend or continue treatment.
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups of cases and controls completely randomly based on the quadruple random block permutation method. Drug injection is done by a person who does not know about the condition of nausea and vomiting of the patient by a colleague who does not know the type of drug injected to the patient.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jondishapur University of Medical Sciences
Street address
No 80,eastern 12 st,kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155973679
Approval date
2023-10-10, 1402/07/18
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1402.129

Health conditions studied

1

Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting

Primary outcomes

1

Description
Nausea and vomiting
Timepoint
30, 15, 45, 60, 75 and 95 minutes after intravenous granisetron injection.
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A vial of 3 mg intravenous granisetron
Category
Treatment - Drugs

2

Description
Control group: 4 mg of intravenous ondansetron
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan and Emam Khomeini hospital
Full name of responsible person
Ali Vefagh nematollahi
Street address
No80,eastern 12th st,kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155973679
Phone
+98 61 3352 5320
Email
vefagh.a@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sahand Jorfi
Street address
no 80 , eastern 12th st, kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155973679
Phone
+98 61 3392 5320
Email
vefagh.a@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Vefagh nematollahi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
no 80,eastern 12th st,kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155973679
Phone
+98 61 3392 5320
Email
vefagh.a@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Vefagh nematollahi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
No 80,eastern 12th st,kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155973679
Phone
+98 61 3392 5320
Email
vefagh.a@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Vefagh nematollahi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
no 80,eastern 12th st,kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155973679
Phone
+98 61 3392 5320
Email
vefagh.a@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Loading...