Effect of Plazil on Ultrasound Quantitative and Qualitative Criteria for Gastrointestinal Infarction in Patients with Incomplete Fasting Time
Design
Clinical trial with two groups: Plasma and placebo, parallel groups, double blind, randomization
Settings and conduct
Patients who have consumed solid food for fewer than 8 hours or consumed fluids in fewer than 2 hours and referred to Imam Hossein Hospital Operating Room or patients referred to Imam Hossein Hospital Emergency. After obtaining full consent and explanations on how the project will be implemented, enter the study. Patients were randomly assigned to receive either 10 mg (2 cc) or 2 cc distilled water based on a randomized number table and baseline values were recorded in all groups.
Participants/Inclusion and exclusion criteria
All patients who are admitted to the operating room of Imam Hussein Hospital emergency room have an NPO time of fewer than 8 hours for solids or less than 1 hour for clear fluids.
Intervention groups
Plasil group
Placebo group
Main outcome variables
Gastric antral grade
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120430009593N12
Registration date:2020-02-17, 1398/11/28
Registration timing:retrospective
Last update:2020-02-17, 1398/11/28
Update count:0
Registration date
2020-02-17, 1398/11/28
Registrant information
Name
Elham Memary
Name of organization / entity
Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 21 7755 8082
Email address
drmemary@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
2019-06-22, 1398/04/01
Actual recruitment end date
2019-10-22, 1398/07/30
Trial completion date
2019-10-22, 1398/07/30
Scientific title
The effect of plasil administration on criterias of gastric emptying according to sonography in urgent surgical patients with incomplete NPO time.
Public title
Effect of plasil on criterias of gastric emptying
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who are admitted to the operating room of Imam Hossein Hospital with an NPO time of fewer than 8 hours for solids or less than 1 hour for clear fluids
Have enough time to do ultrasound and study
Patient consent after explanation
No contraindication for the administration of plasil
The patient has the ability to position himself properly for the ultrasound
The patient does not have gastrointestinal obstruction
The patient has no history of gastric surgery
Do not have hyaline rickets
The patient has no history of diabetes
BMI < 35
The patient has no reflux problem
The patient should not be treated with stimulants or gastrointestinal drugs
Exclusion criteria:
After administration of plasil or placebo, the patient consumes food or water
Vomiting after administration of plasil or placebo
Age
From 15 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
• Randomization method: Simple randomization
• Randomization Unit: based on patient
• Randomization Tool: Random Number Table - block stratified randomization software wnidow version 6.0
Using this software, a random number table is created and the sample list is divided into two groups of 30 each.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants entrance into the case and control groups on the basis of a randomized number table. They also provide a package containing 30 medications and 30 placebo for the doctor. The doctor prescribes the medication to patients Blindly.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
thics committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak Street, University Blvd
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-05-26, 1398/03/05
Ethics committee reference number
IR.SBMU.MSP.REC.1398.186
Health conditions studied
1
Description of health condition studied
Aspiration
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Gastric antral grade
Timepoint
Measurement of gastric antrum at baseline and 30 min after injection
Method of measurement
Ultrasound
Secondary outcomes
1
Description
Decrease in Aspiration Mortality
Timepoint
Gastric antrum measurement at baseline and 30 min after injection
Method of measurement
Ultrasound
Intervention groups
1
Description
As plasil accelerates gastric emptying, we used this drug, which is called metoclopramide, and was administered to patients with vial injection of 4 cc, equivalent to 1 mg in adults.It was administered 2 times and the ultrasound of patients was performed 2 times by radiologist and assistant professor of Imam Hossein Hospital.
Category
Treatment - Drugs
2
Description
Control group: placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Operating Room of Imam Hossein Hosp
Full name of responsible person
Dr Elham Memary
Street address
Imam Hossien Hospital, Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 8001
Email
drmemary@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
University Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
198574443
Phone
+98 21 2243 9781
Email
mpajouhesh@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
Dr Marzieh Rostami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Hossien Hospital, Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 8001
Email
marzieh.rostami@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
dr Elham Memari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hossien Hospital, Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 8001
Email
drmemary@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Elham Memari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hossien Hospital, Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 8001
Email
drmemary@sbmu.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available