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General information
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40
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2019-01-14, 1397/10/24
2019-05-01, 1398/02/11
2019-05-01-14 00:00:00
2020-01-14, 1398/10/24
2019-12-20, 1398/09/29
20202019-0112-1420 00:00:00
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2019-05-01, 1398/02/11
2019-05-01 00:00:00
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2019-12-20, 1398/09/29
2019-12-20 00:00:00
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2019-12-20, 1398/09/29
2019-12-20 00:00:00
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The "expected recruitment start date" and consequently the "expected recruitment end date" were
written based on the code of ethics issuance date, while the start of patient recruitment was expected and organized to commence from 1st May 2019 which is after the issuance of IRCT Code . Therefore other related items were updated as well, namely the "Actual recruitment start date", "Actual recruitment end date", and "Trial completion date" respectively.
The "expected recruitment start date" and consequently the "expected recruitment end date" were written based on the code of ethics issuance date, while the start of patient recruitment was expected and organized to commence from 1st May 2019 which is after the issuance of IRCT Code . Therefore other related items were updated as well, namely the "Actual recruitment start date", "Actual recruitment end date", and "Trial completion date" respectively.
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"تاریخ شروع بیمار گیری مورد انتظار" و بالتبع آن "تاریخ پایان بیمار گیری مورد انتظار" مبتنی بر تاریخ صدور کد اخلاق ذکر شده بود در حالیکه آغاز بیمارگیری برای پس از صدور کد IRCT پیش بینی و برنامه ریزی شده بود. سایر آیتم های مرتبط و مترتب به آن دو تاریخ یعنی "تاریخ شروع بیمارگیری تحقق یافته " و "تاریخ پایان بیمارگیری تحقق یافته " نیز به تبع آنها به روز رسانی شد، همچنین "تاریخ خاتمه کارآزمایی "
.
"تاریخ شروع بیمار گیری مورد انتظار" و بالتبع آن "تاریخ پایان بیمار گیری مورد انتظار" مبتنی بر تاریخ صدور کد اخلاق ذکر شده بود در حالیکه آغاز بیمارگیری برای پس از صدور کد IRCT پیش بینی و برنامه ریزی شده بود. سایر آیتم های مرتبط و مترتب به آن دو تاریخ یعنی "تاریخ شروع بیمارگیری تحقق یافته " و "تاریخ پایان بیمارگیری تحقق یافته " نیز به تبع آنها به روز رسانی شد، همچنین "تاریخ خاتمه کارآزمایی " .
Protocol summary
Study aim
Evaluation of the effectiveness of oral gabapentin on the use of sedative medications in patients undergoing mechanical ventilation in intensive care units in order to design a method for reducing the use of sedative medications in ICU
Design
In Imam Hossein Hospital, during a 6 month period we categorize all patients in ICU who are under mechanical ventilation and meet the inclusion criteria into two groups of intervention (administration of gabapentin) and control (placebo) based on block randomization
The present study is triple-blinded, so that the ICU nurse, the second ICU attending and the patient are not aware of the type of medication or placebo. To this end, the first ICU attending identifies eligible patients to be recruited into the study. The objectives of the study are explained to the patient's eligible family member and if they are willing to participate in the research project, written consent will be obtained from them.
Settings and conduct
This is a randomized 3-blinded clinical trial conducted at Imam Hossein Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1.patients with at least 18 years of age . 2. patients under mechanical ventilation for more than 3 days
Exclusion criteria: 1.Renal Disease 2. A history of acute neurological condition or neuromuscular disease. 3. haemodynamic instability
Intervention groups
In Imam Hossein Hospital, during a six month period we categorize all patients in ICU who are under mechanical ventilation and meet the inclusion criteria into two groups of intervention (administration of gabapentin) and control (placebo).
Main outcome variables
Midazolam and Fentanyl consumption
General information
Reason for update
The "expected recruitment start date" and consequently the "expected recruitment end date" were
written based on the code of ethics issuance date, while the start of patient recruitment was expected and organized to commence from 1st May 2019 which is after the issuance of IRCT Code . Therefore other related items were updated as well, namely the "Actual recruitment start date", "Actual recruitment end date", and "Trial completion date" respectively.
Acronym
IRCT registration information
IRCT registration number:IRCT20190202042588N1
Registration date:2019-04-28, 1398/02/08
Registration timing:prospective
Last update:2020-02-04, 1398/11/15
Update count:1
Registration date
2019-04-28, 1398/02/08
Registrant information
Name
Sara Salarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2665 1601
Email address
sarasalarian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-01, 1398/02/11
Expected recruitment end date
2019-12-20, 1398/09/29
Actual recruitment start date
2019-05-01, 1398/02/11
Actual recruitment end date
2019-12-20, 1398/09/29
Trial completion date
2019-12-20, 1398/09/29
Scientific title
The effect of oral Gabapentin on sedative consumption in mechanically ventilated patients in intensive care unit
Public title
The effect of oral Gabapentin on sedative consumption in mechanically ventilated patients in intensive care unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1. Age should be ove18 years of age.
2. Mechanical ventilation for more than 3 days
The present study is a triple-blind study, so that the nurse of the department, the second assistant professor of ICU and the patient are not aware of the type of medication or placebo. To this end, firstly, by the first assistant professor of the ICU determines the patients eligible for inclusion in the study are by random numbers.
Blinding (investigator's opinion)
Triple blinded
Blinding description
And the relevant nurse will be given instructions on how to evaluate the sedation in each group. But he does not know the type of medicine. The second Assistant Professor of ICU assesses the patient's severity score, but does not know the type of medication.
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ُShahid Beheshti University of Medical Sciences
Street address
Imam Hossein Hospital, Madani Str, Tehran, Iran. Post Code
City
Tehran
Province
Tehran
Postal code
1617763141
Approval date
2019-01-06, 1397/10/16
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.836
Health conditions studied
1
Description of health condition studied
Dependence on respirator [ventilator] status
ICD-10 code
Z99.11
ICD-10 code description
Dependence on respirator [ventilator] status
Primary outcomes
1
Description
Fentanyl consumption
Timepoint
daily
Method of measurement
microgram/kilogram/hour
2
Description
Midazolam consumption
Timepoint
Daily
Method of measurement
milligram/kilogram
3
Description
Gabapentin prescribed dosage
Timepoint
Daily
Method of measurement
milligram
Secondary outcomes
1
Description
Number of days under ventilation
Timepoint
Daily
Method of measurement
Nursing Report
2
Description
Ramsay scale score
Timepoint
hourly
Method of measurement
Scale Score
Intervention groups
1
Description
Intervention group: In this group, the fixed dose of Gabapentin (300mg TDS, daily) dissolved in 5cc normal saline is administered through nasogastric tube , and then, if necessary, with the aim of maintaining an Ramsay Score Scale rating of between 2 and 3, fentanyl 0.5 - 2 μg / kg / hr) and midazolam (0.05-0.1 mg / kg) are given intravenously.
Category
Treatment - Drugs
2
Description
Control group: For the control group, the placebo solution which is dissolved in 5 ml of normal saline will be prescribed via NGT, and then, if necessary, with the aim of maintaining the rate of the RSS between 2 to 3, Fentanyl (0.5-2 μg / kg / hr) and Midazolam (0.05-0.1 mg / kg) will be prescribed intravenously
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein Medical and Educational Center
Full name of responsible person
Sara Salarian
Street address
Shahid Madani Str
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 8001
Email
sarasalarian@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Arabi Str, Yemen Str
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 2202
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
Sara Salarian
Position
َAssistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani Str
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 8001
Email
sarasalarian@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Memari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani Str
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 73430
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
Sara Salarian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani Str
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 8001
Email
sarasalarian@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
Yes - There is 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
Title and more details about the data/document
The whole potential data after being unidentifiable is published
When the data will become available and for how long
From 1400
To whom data/document is available
Medical Society
Under which criteria data/document could be used
Contributing to studies
From where data/document is obtainable
sarasalarian@sbmu.ac.ir
What processes are involved for a request to access data/document