The effect of dexmedetomidine as adjuvant analgesia on postoperative delirium, and perioperative and postoperative arrythmia and hemodynamics in opium user patients undergoing open heart surgery
The effect of dexmedetomidine as adjuvant analgesia on delirium and perioperative and postoperative arrythmia and hemodynamics in opium user patients undergoing open heart surgery
Design
This is a prospective randomized clinical trial study on patients with a history of opioid addiction who are candidates for cardiac bypass surgery under general anesthesia in the operating room of Kausar Semnan Hospital.
Settings and conduct
kosar hospital, semnan
Participants/Inclusion and exclusion criteria
Inclusion criteria
history of opioim addiction
Elective heart surgery candidate
Exclusion criteria
Weight less than 50 kg
History of head trauma or neurological lesions
Liver failure
History of allergy to dexdetomidine
Patients with cardiac EF below 30%
Patients who need an intra-aortic balloon pump
Any unforeseen conditions and malfunction of the pump occur during surgery
Clamping of the aorta takes more than 2 hours
Patients with a history of stroke
Patients should have any disorder of level of consciousness before the operation
Patients have a history of congestive heart failure
Patients with chronic renal failure or history of dialysis
History of arrhythmia or heart surgery in the past
Lack of informed consent
Intervention groups
An intraoperative group plus common anesthesia protocol, loading dose: 6mcg/kg/hr intravenous dexmedetomidine with maintenance drip of 0.2 mcg/kg/hour- 1 mcg/kg/hour will be injected.
Main outcome variables
deliruim
cognitive function
arythmia
hemodynamics
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230603058373N1
Registration date:2023-12-14, 1402/09/23
Registration timing:registered_while_recruiting
Last update:2023-12-14, 1402/09/23
Update count:0
Registration date
2023-12-14, 1402/09/23
Registrant information
Name
Kiarash Roustai geraylow
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2285 8706
Email address
k.roustai@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-12, 1402/09/21
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dexmedetomidine as adjuvant analgesia on postoperative delirium, and perioperative and postoperative arrythmia and hemodynamics in opium user patients undergoing open heart surgery
Public title
The effect of dexmedetomidine as adjuvant analgesia on postoperative delirium, and perioperative and postoperative arrythmia and hemodynamics in opium user patients undergoing open heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
history of opium addiction
candidate for elective open heart surgery
Exclusion criteria:
weight<50kg
history of trauma or neurological lesions
liver failure
dexmedetomidine allergy
EF<30%
aortic pump requirement
any unpredictable circumstances or pump failure during surgery
aortic clamp>2h
history of cerebral stroke
Impaired level of consciousness
history of heart failure
kidney failure or history of dialysis
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
These patients were randomized into two groups using permuted block randomization with 6 blocks (these patients are matched in terms of gender and age ±5 years). .
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to place the research units in two control and intervention groups and to create a random sequence, sealed envelopes were used. In this way, inside half of the envelopes, the letter c meaning the control group and inside the other half, the letter I meaning the intervention group. Then, each of the research units was asked to select an envelope to determine which group they belong to.
The participant and the outcome evaluators and dsmb were unaware of the assigned group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Semnan University Of Medical Sciences and Health Services
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran.
City
semnan
Province
Semnan
Postal code
35147-99442
Approval date
2023-03-13, 1401/12/22
Ethics committee reference number
IR.SEMUMS.REC.1401.307
2
Ethics committee
Name of ethics committee
Research Ethics Committees of Semnan University Of Medical Sciences and Health Services
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran.
City
semnan
Province
Semnan
Postal code
35147-99442
Approval date
2023-03-13, 1401/12/22
Ethics committee reference number
IR.SEMUMS.REC.1401.308
Health conditions studied
1
Description of health condition studied
post operative delirium
ICD-10 code
F05.8
ICD-10 code description
Other delirium
2
Description of health condition studied
cardiac surgery complications
ICD-10 code
T82.9
ICD-10 code description
Unspecified complication of cardiac and vascular prosthetic device, implant and graft
Primary outcomes
1
Description
delirium
Timepoint
daily
Method of measurement
confusion assessment method
2
Description
arrhythmia
Timepoint
perioperative and postoperative
Method of measurement
checklist
Secondary outcomes
1
Description
postoperative pain
Timepoint
every 4h
Method of measurement
visual analog scale
2
Description
cognitive function
Timepoint
preoperative and postoperative
Method of measurement
mini mental state exam
Intervention groups
1
Description
Intervention group: In the intervention group, in addition to the common anesthesia protocol, loading dose: 6 mcg/kg/hr intravenous dexmedetomidine with maintenance drip of 0.2 mcg/kg/hour – 1 mcg/kg/hour will be injected.
Category
Treatment - Drugs
2
Description
Control group: common anesthesia protocol
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar hospital
Full name of responsible person
Mohammad Forozashfard
Street address
Amin street, Nirogah square, Golestan
City
Semnan
Province
Semnan
Postal code
35198 99951
Phone
+98 23 3344 1022
Email
kosarhos@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
99951-35198
Phone
+98 23 3344 1022
Email
majidmir@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
10
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
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Foroozeshfard
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Semnan
City
Semnan
Province
Semnan
Postal code
99951-35198
Phone
31420000-023
Email
mff45@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Foroozeshfard
Position
Professsor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Semnan
City
Semnan
Province
Semnan
Postal code
99951-35198
Phone
31420000-023
Email
mff45@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Foroozeshfard
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Semnan
City
Semnan
Province
Semnan
Postal code
99951-35198
Phone
31420000-023
Email
mff45@yahoo.com
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