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The effect of combination of Neostigmine and Metoclopramide on gastric residual volume in mechanically ventilated ICU patients

Protocol summary

Summary
The aim of this Triple blind randomized clinical trial is comparing the effect of Metoclopramide , Neostigmine and combination of Metoclopramide and Neostigmine on gastric residual volume in mechanically ventilated ICU patients. 90 patients, who qualified for study entry, randomly allocate in three equal 30patients intervention groups. The first group receives 2.5mg Neostigmine, the second group receives 10 mg Metoclopramide and the third group receives both of them in 100 cc Normal Saline infused at 30 minutes. Then gastric residual volume will be checked 0, 3, 6, 9 and 12 hours after intervention. Also heart rate, blood pressure, Na, K, Mg, Hb, WBC, albumin and SOFA are measured before intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201408104365N16
Registration date: 2015-01-01, 1393/10/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-01-01, 1393/10/11
Registrant information
Name
Afshin Gholipour Baradari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 1245
Email address
gholipourafshin@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mazandaran University of Medical Sciences
Expected recruitment start date
2014-03-01, 1392/12/10
Expected recruitment end date
2015-02-01, 1393/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combination of Neostigmine and Metoclopramide on gastric residual volume in mechanically ventilated ICU patients
Public title
Combination of Neostigmine and Metoclopramide to reduce gastric residual volume in mechanically ventilated ICU patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient family agreement and informed written consent; under mechanical ventilation; nutrition via gastric tube; gastric residual volume greater than 120 cc; age between 20 and 60 years Exclusion criteria: diabetes; heart rate<60; heart blocks and arrhythmias; systolic BP<90 mmHg; hypothermia (core temperature<35); renal failure (serum Creatinin>1.5 in two consecutive test); prokinetic agents consumption during 8 hours before intervention; recent surgery on GI tract within 10 days; pregnancy and breast feeding; extrapyramidal sign; bronchospasm; hypokalemia (K<3 meq/L); known sensitivity to Neostigmine and metoclopramide; GI bleeding.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
sari
Postal code
46175866
Approval date
2013-12-04, 1392/09/13
Ethics committee reference number
92-163

Health conditions studied

1

Description of health condition studied
The relation of combination of Neostigmine and Metoclopramide with gastric residual volume in mechanically ventilated ICU patients
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Gastric residual volume
Timepoint
0,3,6,9,12 hours after intervention
Method of measurement
Gastric lavage

Secondary outcomes

1

Description
Albumin, hemoglobin, WBC, Na, K, Mg
Timepoint
Before trial
Method of measurement
laboratory kit

2

Description
Hear rate, blood pressure
Timepoint
During trial
Method of measurement
Cardiac monitoring

3

Description
SOFA
Timepoint
before trial
Method of measurement
SOFA calculator

Intervention groups

1

Description
Intrvention group 1: Neostigmine 2.5 mg in 100 ml normal saline infused during 30 minute at the beginning of trial
Category
Treatment - Drugs

2

Description
Intrvention group 2: Metoclopramide 10 mg in 100 ml normal saline infused during 30 minute at the beginning of trial
Category
Treatment - Drugs

3

Description
Intrvention group 3: Neostigmine 2.5 mg + Metoclopramide 10 mg in 100 ml normal saline infused during 30 minute at the beginning of trial
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini General Hospital
Full name of responsible person
Afshin Gholipour Baradari, MD, CCMF, Associate Professor
Street address
Imam Khomeini General Hospital, Amir St.
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati, MD
Street address
Mazandaran University of Medical Sciences, Moallem Square- Sari- Iran
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Afshin Gholipour Baradari, MD
Position
CCMF, Associate Professor, Chief of ICU
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Moallem Square, Sari, Iran
City
Sari
Postal code
48175-866
Phone
+98 11332612458
Fax
+98 15 1326 2679
Email
gholipourafshin@mazums.ac.ir; gholipourafshin@yahoo.com
Web page address
www.mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Afshin Gholipour Baradari, MD
Position
CCMF, Associate Professor, Chief of ICU
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Moallem Square, Sari, Iran
City
Sari
Postal code
48175-866
Phone
+98 11 3326 2679
Fax
+98 11 3326 2679
Email
gholipourafshin@yahoo.com
Web page address
www.mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Abolfazl Firouzian, MD
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Khomeini General Hospital, Amir St
City
Sari
Postal code
48175-866
Phone
+98 11 3326 2679
Fax
+98 11 3326 2679
Email
ab.firouzian@gmail.com
Web page address
www.mazums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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