Protocol summary

Study aim
Comparing the effect of intravenous neostigmine and metoclopramide on gastric residual volume of mechanically ventilated intensive care unit patients
Design
This assessment is a clinical trial in phase 3, patients with inclusion criteria for study, are considered as study group. In this study, 100 patients are selected. Patients are categorized based on non randomization method, 50 patients in the neostigmine group and 50 patients in the metoclopramide group. Accordingly, before starting the drug infusion and 3, 6, 9 and 12 hours after the start of the infusion, the gastric residual volume is evaluated by aspirate with a gavage syringe.
Settings and conduct
This study was carried out as a clinical trial at the Khatam Al Anbia Hospital in Zahedan, Also the study will also be single blinded in which patients will be blinded in study.
Participants/Inclusion and exclusion criteria
Inclusion criteria included as age between 20 and 50 years, patients under mechanical ventilation and patients with enteral nutrition through nasogastric tube. Also exclusion criteria included as previous use of beta blockers, heart block, bradycardia (heart rate less than 60) before inclusion, hypothermia in the form of central temperature below 35 degrees, kidney Failure (CR> 1.5), use erythromycin or cisapride within 8 hours before starting the study, recent surgery on stomach or digestive tract within the last ten days, signs and symptoms of bowel obstruction, pregnancy and lactation, active bronchospasm, extrapyramidal symptoms, sensitivity to neostigmine and active gastrointestinal bleeding.
Intervention groups
In the first group, neostigmine was used at 2.5 mg / 100 ml of normal saline and In the second group used metoclopramide at a dose of 10 mg / 100 ml of normal saline.
Main outcome variables
gastric residual volume

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190804044432N1
Registration date: 2019-08-18, 1398/05/27
Registration timing: prospective

Last update: 2019-08-18, 1398/05/27
Update count: 0
Registration date
2019-08-18, 1398/05/27
Registrant information
Name
Sara Saneie moqadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3322 6841
Email address
sms18768@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-08, 1398/06/17
Expected recruitment end date
2020-09-06, 1399/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of intravenous neostigmine and metoclopramide on gastric residual volume of mechanically ventilated intensive care unit patients
Public title
Comparing neostigmine and metoclopramide on gastric residual volume
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 50 years Patients under mechanical ventilation Patients with enteral nutrition through nasogastric tube
Exclusion criteria:
Previous use of beta blockers Heart Block Bradycardia (heart rate less than 60) before inclusion Hypothermia in the form of central temperature below 35 degrees Kidney Failure (CR> 1.5) Use Erythromycin or Cisapride within 8 hours before starting the study Recent surgery on stomach or digestive tract within the last ten days Signs and symptoms of bowel obstruction Pregnancy and lactation Active bronchospasm Extrapyramidal symptoms Sensitivity to Neostigmine Active gastrointestinal bleeding
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
This means that patients in groups do not know the used drugs, and drugs has similar packaging.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
9816743463, Zahedan University of Medical Sciences, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-07-27, 1398/05/05
Ethics committee reference number
IR.ZAUMS.REC.1398.185

Health conditions studied

1

Description of health condition studied
dilatation of volume
ICD-10 code
K31.0
ICD-10 code description
Acute dilatation of stomach

Primary outcomes

1

Description
gastric residual volume
Timepoint
Before starting the drug infusion and 3, 6, 9 and 12 hours after the start of the infusion
Method of measurement
Aspirate with a gavage syringe

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the first group, neostigmine, manufactured by Caspian Tamin Pharmaceutical Company, was used at 2.5 mg / 100 ml of normal saline, intravenously and one time.
Category
Treatment - Drugs

2

Description
Intervention group: In the second group used metoclopramide, manufactured by Caspian Tamin Pharmaceutical Company, at a dose of 10 mg / 100 ml of normal saline, intravenously and one time.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam Al Anbia Hospital
Full name of responsible person
Masome Khoshfetrat
Street address
9815733169, Jamejam Avenue, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3329 5564
Email
MasomeKhoshfetrat@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Shahraki
Street address
9816743463, Zahedan University of Medical Sciences, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5725
Email
m_Shahrakim@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Sara Saneie Moqadam
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
9816743463, Zahedan University of Medical Sciences, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5725
Email
m_Shahrakim@zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sara Saneie Moqadam
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
9816743463, Zahedan University of Medical Sciences, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5725
Email
m_Shahrakim@zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sara Saneie moqadam
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
9816743463, Zahedan University of Medical Sciences, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5725
Email
m_Shahrakim@zaums.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
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