Gastric residual volume evaluation with ultrasonography after intravenous ondansetron and metoclopramide and neostigmine :A Double Blind Randomized clinical Trial
Comparison of the therapeutic effect of ondansetron, metoclopramide and neostigmine in reducing gastric residual volume in intensive care unit patients under mechanical ventilation
Design
Our study is the clinical trials of Phase 3, which focus on the effects of the three drugs ondansetron and neostigmine and metoclopramide on the gastric residual volume according to the three groups of ten that patients are using from the random table to these three groups by examining the three groups of the original sample size.
Settings and conduct
Our study group selected patients with mechanical ventilation attached to the nasogastric tube who will be admitted to the medical intensive care unit of Masih Daneshvari. And will be ultrasound by an intensive care physician who is not aware of the type of drug being administered
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients 18 to 80 years, Patients hospitalized in ICU, Patients with nasogastric tube or percutaneous gastrostomy tube
Exclusion criteria:
Do not place the nasal gastric tube in the stomach,Prisoners, Ileus,
Long-term fasting planning,The remaining volume of the stomach is not examined by nurses for any reason.
Intervention groups
Group: Ondansetron: Patients are given 8 mg of ondansetron intravenously infused twice daily for 20 minutes.
Group: Metoclopramide: Patients are given 10 mg intravenous metoclopramide infusion three times daily for 20 minutes.
Group: Neostigmine: Patients given 2.5 mg intravenous neostigmine infusion within 20 minutes once daily
And after five half-lives of drugs, the volume of the gastric antrum of the patients was measured by ultrasonography on four consecutive days 3 hours after gavage.
Main outcome variables
Gastric residual volume on ultrasound
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190215042716N1
Registration date:2020-01-11, 1398/10/21
Registration timing:registered_while_recruiting
Last update:2020-01-11, 1398/10/21
Update count:0
Registration date
2020-01-11, 1398/10/21
Registrant information
Name
navid shafigh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 3378
Email address
n.shafigh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-22, 1398/05/31
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Gastric residual volume evaluation with ultrasonography after intravenous ondansetron and metoclopramide and neostigmine :A Double Blind Randomized clinical Trial
Public title
Gastric residual volume evaluation with ultrasonography after intravenous ondansetron and metoclopramide and neostigmine :A Double Blind Randomized clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18 to 80 years
Patients hospitalized in ICU
Patients with nasogastric tube or percutaneous gastrostomy tube
Exclusion criteria:
Do not place the nasal gastric tube in the stomach
Prisoners
Ileus
Long-term fasting planning
The remaining volume of the stomach is not examined by nurses for any reason
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who met the inclusion criteria were selected by random number table from left to right reading method. The numbers were between 00 and33 in group A (ondansetron) and patients with numbers between 33 and 66in group B (metoclopramide) and patients with numbers from 66 to99were divided into intervention group C (Neostigmine) .
(Randomized Table is a set of numbers that are generated without a specific pattern and order in a completely random way and are tabulated. In order to use this table, the researcher must pre-determine the numbers to read and the default for the intervention group numbers).
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients and their legal guardians will first receive consent and patients will be included in the study, and this study will be conducted according to the ethical standards stated in the 1964 Helsinki Declaration. Then the patients and their legal counsel. It is explained that all drugs are common drugs in our treatment and our study examines their superiority over each other. The nurses will then give the patients a group of drugs that are perfectly matched in shape, color and packaging, and then sonographed by a intensive care physician who has no knowledge of the drug being administered and the remaining gastric volume measured. The information is then subdivided into three groups by the data analyzer and analyzed
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences and Health Services
Gastro-esophageal reflux disease without esophagitis
Primary outcomes
1
Description
Size of gastric residual volume on ultrasound
Timepoint
Patients were studied after 5 half-lives of drug from the third day and 4 hours after morning gavage for the next 4 days.
Method of measurement
Sonography device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Ondansetron: Patients are given 8 mg intravenous ondansetron twice daily for 20 minutes and after five half-lives of medication their gastric volume is measured with sonography four consecutive days 3 hours after gavage.
Category
Treatment - Drugs
2
Description
Intervention group 2: Metoclopramide: Patients are given 10 mg intravenous metoclopramide infused three times daily for 20 minutes and after five half-lives of medication their gastric volume is measured with sonography four consecutive days 3 hours after gavage.
Category
Treatment - Drugs
3
Description
Intervention group3: Neostigmine: Patients are given 2.5 mg intravenous infusion neostigmine for 20 minutes once daily and after five half-lives of medication their gastric volume is measured with sonography four consecutive days 3 hours after gavage.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari hospital
Full name of responsible person
Navid Shafigh
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout,
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 8801 3313
Email
navid_shafigh2005@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Babak Shokri
Street address
Masih Daneshvari Hospital,Movahed Danesh Ave,
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
b-shokri@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Navid Shafigh
Position
Residency
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2111 9279
Email
navid_shafigh2005@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Navid Shafigh
Position
Residency
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2912 3100
Email
navid_shafigh2005@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Navid Shafigh
Position
Residency
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2912 3100
Email
navid_shafigh2005@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after unidentifiable people
When the data will become available and for how long
Start of access period from 1400
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Help to research
From where data/document is obtainable
navid_shafigh2005@yahoo.com
What processes are involved for a request to access data/document
Once the email has been sent and the email confirmation has been valid, the documentation will be sent to their email within one month.