Evaluation of Effectiveness of Different Dosage of Neostigmine in Combination with Metoclopramide, on Gastric Residual Volume, in Enteral Nutrition, in Hospitalized Patients in Intensive Care Unit
The aim of this study was to evaluate the effect of different doses of Neostigmine in combination with Metoclopramide , on the gastric residual volume of trauma patients in the intensive care unit will be done that under enteral nutrition via NG.Tube or OG.Tube.
Design
This study is 165 patients (in three groups of 55) traumatized patients referring to Rasoul-E Akram Hospital in Tehran divided into three groups A, B and C using block randomized method
Settings and conduct
Patients who are traumatized and referring to Rasoul-E Akram hospital in Tehran and admitted to the intensive care unit. The design of the study is a double-blind, randomized controlled trial. Patients and physicians who examine the status of the patients will be blinded to the intervention type.
Participants/Inclusion and exclusion criteria
Enteral nutrition feeding; after three hours from the last gavage gastric residual volume ≥50% and age 18-60 are inclusion criteria and exclusion criteria are diabetes mellitus disease; heart rate <60 and systolic blood pressure <90.
Intervention groups
(Gold standard group): Metoclopramide will be prescribed five milligrams in every eight hours by IV.slow method during one minute. In addition, one milligram of NASTIGMINE dose in dilute solution of 100 cc Normal Saline and infusion takes in time 60 minutes. The gavage will be done three hours after the completion of the Neostigmine infusion. patients will be get 300 cc Gavage every three hours.
(Intervention group 1): Metoclopramide will be prescribed five milligrams in every eight hours by IV.slow method during one minute. In addition, one and a half milligrams of NASTIGMINE dose in dilute solution of 100 cc Normal Saline and infusion takes in time 60 minutes. The gavage will be done three hours after the completion of the Neostigmine infusion. patients will be get 300 cc Gavage every three hours.
(Intervention group 2): Metoclopramide will be prescribed five milligrams in every eight hours by IV.slow method during one minute. In addition, two milligrams of NASTIGMINE dose in dilute solution of 100 cc Normal Saline and infusion takes in time 60 minutes. The gavage will be done three hours after the completion of the Neostigmine infusion. patients will be get 300 cc Gavage every three hours
Main outcome variables
The gastric remaining volume after three hours is the primary outcome.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170903036041N1
Registration date:2017-12-16, 1396/09/25
Registration timing:registered_while_recruiting
Last update:2017-12-16, 1396/09/25
Update count:0
Registration date
2017-12-16, 1396/09/25
Registrant information
Name
Omid Moradi Moghadam
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 9233
Email address
moradimoghadam.o@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-04-16, 1397/01/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effectiveness of Different Dosage of Neostigmine in Combination with Metoclopramide, on Gastric Residual Volume, in Enteral Nutrition, in Hospitalized Patients in Intensive Care Unit
Public title
Evaluation of Effectiveness of Different Dosage of Neostigmine in Combination with Metoclopramide, on Gastric Residual Volume
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Enteral nutrition feeding
After three hours from the last gavage gastric residual volume ≥50%
Age 18-60
Exclusion criteria:
Diabetes mellitus disease
Atrioventricular block
Heart rate <60
Systolic blood pressure <90
Within 10 days Gastrointestinal surgery
Clinical signs of Gastrointestinal obstruction
Bronchospasm or Asthma history
In 24 hours administration of Prokinetic drugs
Sensitivity to Metoclopramide or Neostigmine
Kidney failure or Creatinine >2 milligram/deciliter
Hypokalemia
Concomitant medication with Cyclosporine
Digoxin and Monoamine Oxidase inhibitors
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
165
Randomization (investigator's opinion)
Randomized
Randomization description
Traumatized patients divided into three groups A, B and C using block randomized method. In this study a person who is not in the study process after the admission of the patient, allocated the relevant intervention to each patient with the relevant block and notifies the director of the research team.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blind study that patients or their companions after verifying the informed consent of the study, will be blind the type of intervention. Physicians and carers of patients which examines the clinical status of patients will be blind to the type of intervention that patients are taking.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Science
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-10-03, 1396/07/11
Ethics committee reference number
IR.IUMS.REC 1396.31529
Health conditions studied
1
Description of health condition studied
Gastric residual volume
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Gastric residual volume
Timepoint
three hours after the completion of the infusion
Method of measurement
Cc
Secondary outcomes
1
Description
Age
Timepoint
At the time of entering the study
Method of measurement
Chronological age
2
Description
Blood pressure
Timepoint
Recorded during the measurement of the gastric remaining volume
Method of measurement
mmHg (millimeters of mercury)
3
Description
Respiratory rate
Timepoint
Recorded during the measurement of the gastric remaining volume
Method of measurement
The number of movements indicative of inspiration and expiration per unit time
4
Description
Heart rate
Timepoint
Recorded during the measurement of the Gastric remaining volume
Method of measurement
Number of contractions of the heart per minute (bpm)
Intervention groups
1
Description
(Gold standard group): Metoclopramide will be prescribed five milligrams in every eight hours by IV.slow method during one minute. In addition, one milligram of Neostigminedose in dilute solution of 100 cc Normal Saline and infusion takes in time 60 minut
Category
Treatment - Drugs
2
Description
(Intervention group 2): Metoclopramide will be prescribed five milligrams in every eight hours by IV.slow method during one minute. In addition, two milligrams of Neostigmine dose in dilute solution of 100 cc Normal Saline and infusion takes in time 60 mi
Category
Treatment - Drugs
3
Description
(Intervention group 1): Metoclopramide will be prescribed five milligrams in every eight hours by IV.slow method during one minute. In addition, one and a half milligrams of Neostigmine dose in dilute solution of 100 cc Normal Saline and infusion takes in
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat-e Rasoul Akram hospital
Full name of responsible person
Omid Moradi Moghadam
Street address
Hazrat-e Rasoul Akram hospital, Niyayesh St, Sattar Khan St
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6653 9255
Fax
+98 21 6653 9255
Email
moradimoghadam.o@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellery for research Iran University of Medical Sciences
Full name of responsible person
Kazem Malakouti
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6653 9255
Email
moradimoghadam.o@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellery for research Iran 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
Iran University of Medical Science
Full name of responsible person
Omid Moradi Moghadam
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 912 124 4560
Fax
Email
moradimoghadam.o@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Omid Moradi Moghadam
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6653 9255
Fax
Email
moradimoghadam.o@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Omid Mordi Moghadam
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6653 9255
Fax
Email
moradimoghadam.o@iums.ac.ir
Web page address
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