The aim of this study was to compare the long-term infusion of Dexmedetomidin versus midazolam in mechanically ventilated patients admitted to the intensive care unit. Twenty patients will be enrolled in each group. Patients will be randomly divided into two groups. Patients in Group Dexmedetomidin will receive 0.4 to 0.8 micrograms per kilogram per hour of Dexmedetomidin to achieve a RASS between -1 to -2. Patients in Group midazolam will receive 0.02 to 0.04 miligrams per kilogram of midazolam to achieve the RASS between -1 to -2. To assess patient consciousness, washout period (interruption of sedation) from 7 am until 9 am will be done in all patients. The purpose of this evaluation will be the assessment of 4 task including opening of the eyes with calling, follow-up of researchers and clinicians with eyes, hand pressure and protrusion of the tongue. For all patients, the time needed to reach the target RASS, ration of duration of time spent in target RASS to total duration of sedation, need to increasing the drug dose or addition of other sedative medications will be recorded. The primary outcome variable is duration of mechanical ventilation and the secondary outcome variable is length of ICU stay and mortality are.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608192582N16
Registration date:2016-11-08, 1395/08/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-08, 1395/08/18
Registrant information
Name
Ata Mahmoodpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 116 0888
Email address
mahmoodpoora@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing longterm infusion of dexmedetomidin versus midazolam in mechanically ventilated patients admitted to intensive care unit
Public title
comparing infusion of dexmedetomidin versus midazolam in patients admitted to intensive care unit
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: all patients with more than 18 years old who need to be admitted to ICU and ungergone mechanical ventilation
exclusion criteria: allergy to recital drug; needing the infusion of both drugs;resistant to treatment hypotention; pregnancy or lactation; addiction history; CNS disease; dialysis history; hepatic function disorder; EF<30%
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Approval date
2016-07-25, 1395/05/04
Ethics committee reference number
IR.TBZMED.REC.1395.406
Health conditions studied
1
Description of health condition studied
unconsciousness
ICD-10 code
G96.9
ICD-10 code description
Disorder of central nervous system, unspecified
Primary outcomes
1
Description
duration of mechanical ventilation
Timepoint
Daily
Method of measurement
counting the days under mechanical ventilation
Secondary outcomes
1
Description
ICU length of stay
Timepoint
daily
Method of measurement
counting days of ICU stay
2
Description
mortality
Timepoint
daily
Method of measurement
counting mortality
Intervention groups
1
Description
intervention group
dexmedetomidine
0.4-0.8 µg/kg/h
Category
Treatment - Drugs
2
Description
control group
Midazolam
0.02-0.04 mg/kg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
General ICU of Imam Reza hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
General ICU, Imam Reza hospital
City
Tabriz
2
Recruitment center
Name of recruitment center
ICU of Shohada hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
ICU, Shohada hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Afshin Ghalehgolab Behbahani
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
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 Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Nina Pilevar
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Daneshgah street
City
Tabriz
Postal code
Phone
00
Fax
Email
ninapilevar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Position
Associate professor
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Daneshgah street
City
Tabriz
Postal code
Phone
+98 41 3334 1994
Fax
Email
amahmoodpoor@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nina Pilevar
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Daneshgah street
City
Tabriz
Postal code
Phone
00
Fax
Email
ninapilevar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)