The effect of dexmedetomidine infusion during cardiac surgery on reducing the prevalence of postoperative delirium
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 60 patients. Random numbers in Excel software are used for randomization
Settings and conduct
The study was performed in a double-blind manner at Modarres Hospital and on patients undergoing heart surgery. The Intensivist who measure patient delirium is not aware of the study groups. Only the physician responsible for the patient's anesthesia knows that the perfused drug may be Dex and may consider the patient's possible hemodynamic and bradycardia complications
Participants/Inclusion and exclusion criteria
Adult patients referred to the cardiac operating room
Inclusion criteria: 1- Age between 40 to 80 years 2- EF above 20%
Exclusion criteria: 1- Known allergy to dexmedetomidine 2- Taking preoperative antipsychotic drugs 3- Patient's lack of cooperation 4- History of delirium, neuropsychiatric illness and seizures 5- Emergency operation
Intervention groups
Group receiving dexmedetomine infusion during cardiac surgery and group receiving normal saline infusion as placebo
Main outcome variables
Measurement of postoperative delirium based on Richmond's Agitation- sedation scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180724040575N4
Registration date:2020-10-05, 1399/07/14
Registration timing:retrospective
Last update:2020-10-05, 1399/07/14
Update count:0
Registration date
2020-10-05, 1399/07/14
Registrant information
Name
kamal fani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 4095
Email address
kamalfani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
2019-04-21, 1398/02/01
Actual recruitment end date
2019-08-18, 1398/05/27
Trial completion date
2019-08-21, 1398/05/30
Scientific title
Effect of perioperative dexmedetomidine infusion on post operative delirium in on pump heart surgery patients
Public title
Effect of dexmedetomine on delirium
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults candidate for cardiac surgery
Ejection Fraction(EF) >20%
Exclusion criteria:
Known allergy to dexmedetomidine
Taking preoperative antipsychotic drugs
Lack of patient cooperation and satisfaction
History of delirium, neuropsychiatric disorders and seizures
Emergency operation
Age
From 40 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
For assignment in intervention and control groups, a simple randomization method with the help of random numbers of Excel software is used. With the help of the RANDBETWEEN function, we create a column consisting of 30 random numbers between 1 and 60, and by removing duplicate items, we continue this function until the complete production of 30 random numbers. These numbers are the row of participants who are in the intervention group, and naturally the row of numbers that are not in this list of 30 are in the control group. For each row of participants, a closed envelope is prepared by the researcher not present in the operating room, and with the arrival of each patient, the relevant envelope is opened by the project partner in the operating room and the designated group is determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are not aware of the administration of the drug or placebo infused during anesthesia.
Data collector are also unaware of the study group.
Placebo
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
Taleghani Hospital , Velenjak Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Approval date
2019-09-18, 1398/06/27
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.332
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
Primary outcomes
1
Description
Delirium score based on Richmond Agitation Sedation Scale
Timepoint
Evaluation of delirium based on Richmond score before , 6 and 24 h after surgery
Method of measurement
Richmond Agitation Sedation Scale (RASS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, after induction of anesthesia, dex medetomidine at a dose of 0.2 to 0.5 micrograms per kilogram per hour is started as an intravenous infusion and continues until the sternum closes at the end of the operation. Dexmedetomidine made by Exir Company is used with an initial concentration of 200 micrograms in 2 ml, which is dissolved in 50 ml of normal saline made by Shahid Ghazi serum manufacturing company and will be used with a final concentration of 4 micrograms per ml. syringe Pump and 50 ml syringe are used for infusion.
Category
Treatment - Drugs
2
Description
Control group: In this group, after induction of anesthesia, normal saline serum at a dose of 0.1 ml / kg / h is started as an intravenous infusion and continues until the sternum is closed at the end of the operation. Normal saline is prepared in 50 ml syringe and the infusion is performed by a pump syringe.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres Hospital
Full name of responsible person
Kamal Fani
Street address
Taleghani Hospital , Velenjak Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2207 4089
Email
kamalfani@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarqhi
Street address
Shahid Chamran Highway - Yemen St. - Shahid Abbas Arabi St. (Parvaneh) - Next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences - Headquarters Building 2- Floor 5- Deputy of Research and Technology
City
Tehran
Province
Tehran
Postal code
1996911151
Phone
+98 21 2243 2572
Email
kamalfani@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
Kamal Fani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Modarres Hospital, Saadat Abad Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2207 4095
Fax
Email
kamalfani@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kamal Fani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Modarres Hospital, Saadat Abad Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2207 4095
Fax
Email
kamalfani@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kamal Fani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Modarres Hospital, Saadat Abad Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2207 4095
Fax
Email
kamalfani@sbmu.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