Effect of iv metoclopramide on gastric emptying in drug-using patients based on ultrasound criteria
Design
The clinical trial consisted of a control group with parallel groups, a non-randomized phase 3، single blind on 135 patients.the patient will be divided into 3 groups of 45 people.the emergency assistant (clinical caregiver) will select any patient who qualifies for the study and will be in the first group if he or she is a drug user. If he is not a drug user, he will be randomly placed in the second intervention and control group, so that the first person will be in the second iv group and the second person will be in the control group and so on.
Settings and conduct
Randomise patients into opium adiction (D) group or normal group (C),control group (B). all groups will undergo sonography measurements.group (D) will receive 2 cc plasil iv and the (C) Will receive 2 cc of plasil.in group (B) will recieve 2cc n/s in order to placebo The mentioned sonographic variables will be remeasured after 30 minutes in three groups.
Participants/Inclusion and exclusion criteria
Patient age range of 16 to 80 years with BMI less than 35 who have consumed solid food in the last 8 hours or clear liquids in the last 2 hours.Patients with gastrointestinal obstruction, diabetes, a history of gastric surgery or hiatal hernia, or a history of gastrointestinal changes will be excluded.
Intervention groups
Patients divided into 3 groups. The first group of patients with a history of drug use, The second group of patients without a history of drug use and The third group will be the control group. For the first two groups, 10 mg of metoclopramide will be injected intravenously. For the control group, about 2 ml of distilled water of the same volume as metoclopramide will be prescribed
Main outcome variables
Gastric emptying
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20210406050864N1
Registration date:2021-11-07, 1400/08/16
Registration timing:retrospective
Last update:2021-11-07, 1400/08/16
Update count:0
Registration date
2021-11-07, 1400/08/16
Registrant information
Name
Mohamadjavad Yazdipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4486 7051
Email address
mjyazdipooor@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-18, 1400/06/27
Expected recruitment end date
2021-10-19, 1400/07/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of intravenous metoclopramide on gastric emptying in drug-using patients based on ultrasound criteria
Public title
The effect of intravenous metoclopramide on gastric emptying
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients referred to the emergency department between the age of 16 and 80years
All patients referred to the emergency department with BMI less than 35
All patients referred to the emergency department with history of opium use
All patients who had consumed solid food in the past 8 hours or liquids in the previous 2 hours in the intervention group
Exclusion criteria:
Patients who are unable to have an ultrasound for any reason
Patients with a history of diabetes
Patients with a history of gastrointestinal surgery
Patients with suspected gastrointestinal obstruction
Patients taking medication that affects gastrointestinal motility
Patients with a history of inflammatory bowel disease
Patients with a history of irritable bowel disease
Age
From 16 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants and the clinical caregiver who is the assistant in charge of the patient will be fully aware of the type of prescription. But the researcher himself, as well as the outcome assessor and data analyst, will be unaware of prescribing to the groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comitte of shahid beheshti university of medical science
Street address
Yaman Street
City
tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-06-30, 1399/04/10
Ethics committee reference number
Ir.sbmu.msp.rec.1399.154
Health conditions studied
1
Description of health condition studied
Effect of methoclopramide on gastric motility
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
gastric emptying
Timepoint
30min
Method of measurement
sonographic criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: will include patients taking opium with a BMI less than 35. Who have consumed solid food in the last 8 hours or consumed clear liquids in the last 2 hours. After obtaining full consent and explanations on how to implement the plan, these patients will be included in the study and will be monitored and recorded at baseline values. These patients undergo ultrasound in both supine and right lateral position (RLP). After recording the measurements, 10 mg (2 cc) of metoclopramide is administered intravenously to patients. The ultrasound is then repeated 30 minutes later and these measurements will be recorded again. Ultrasound is used to qualitatively examine the material and contents of the stomach (liquid or solid). And antral-gastric grade are classified into three grades: zero, one and two: GRADE 0=absence of fluid GRADE 1 = fluid in RLP position GRAD 2=fluid in both supine and RLP position Quantitative examination will be in the form of Antral cross-sectional area (ACS) and Antral volume measurements. CSA will be calculated by measuring the vertical thickness in the two longitudinal (d1) and anterior-posterior planes (from serosa to serosa) (d2) and using the formula CSA = 3.14 (d1 * d2) 4%. This mathematical model is used to calculate the volume of stomach contents and determine the volume. VOLUME = 27 + (14.6 × RL CSA) _ (1.28 × age)
Category
Treatment - Drugs
2
Description
Control group: will include non-opium user patients with a BMI less than 35. Who have consumed solid food in the last 8 hours or consumed clear liquids in the last 2 hours. And all the interventions performed for intervention group 1 will be performed in the control group.
Category
Treatment - Drugs
3
Description
Control group 2: will include non-opium user patients with a BMI less than 35. Have consumed solid food in the last 8 hours or consumed clear liquids in the last 2 hours. Have consumed solid food in the last 8 hours or consumed clear liquids in the last 2 hours. All interventions in this group will be similar to the intervention group, but instead of administering metoclopramide, 2 ml of distilled water will be injected intravenously (placebo) for these patients.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam hosein hospital
Full name of responsible person
Mohammad javad Yazdipoor
Street address
Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 2380
Fax
+98 21 7755 7069
Email
Mjyazdipooor@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin zarghi
Street address
Yaman St
City
Tehran
Province
Tehran
Postal code
1985717443
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
5
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
Mohamad javad Yazdipoor
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7443 2380
Fax
+98 21 7755 7069
Email
Mjyazdipooor@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohamad javad Yazdipoor
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
98 73432380
Email
Mjyazdipooor@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohamad javad Yazdipoor
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 2380
Email
Mjyazdipooor@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Disagreement of some study participants with sharing of their information