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Evaluating the effect of using dexmedetomidine in inducing and maintaining anesthesia in cardiac surgery patients

Protocol summary

Study aim
determining the effect of using dexmedetomidine in inducing and maintaining anesthesia in cardiac surgery comparing the hemodynamic responses, the incidence of arrhythmia, and the inflammatory factors after operation between groups comparing the post-operative recovery time, the lactate level, blood sugar level, and side effects of the drugs between groups comparing the effects of dexmedetomidine on cardiovascular stress responses during and after open heart surgery
Design
This is a single-center randomized controlled trial (third phase), with balanced randomization [1:1]), double-blind (patients, and investigator), and parallel-group study. 70 patients will be allocated into two groups (35 patients in each). For randomization, sealedenvelope.com online site will use.
Settings and conduct
The study will be performed in the Sayyad Shirazi Hospital in Gorgan. The vital signs and the lactate level will be recorded before, during, and after the induction of the drug. The inflammatory factors will be measured before and ۲۴ hours after surgery.
Participants/Inclusion and exclusion criteria
Inclusion: aged between 18-65 years both sexes Patients under one of these surgery (pump coronary artery bypass, valvular replacement or valvular repair) Informed consent to participate in the study Exclusion: Patients with underlying diseases (serious coagulopathy, inflammation, ...) Patients use these medicines (steroids, anti-inflammatory drugs, immunosuppressive)
Intervention groups
Pretreatment drugs and induction of anesthesia will be the same for all patients. Intervention for maintenance of anesthesia: In Dexmedetomidine group: ۰.۵ mcg/kg/hr of dexmedetomidine infusion, midazolam ۰.۱ – ۰.۲ mg/kg/hr In controlled group: isoflurane ۰.۴% as inhalational agent, midazolam ۰.۱ – ۰.۲ mg/kg/hr
Main outcome variables
hemodynamic responses inflammatory factors, lactate level and post-operative recovery time

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240624062233N1
Registration date: 2024-06-26, 1403/04/06
Registration timing: prospective

Last update: 2024-06-26, 1403/04/06
Update count: 0
Registration date
2024-06-26, 1403/04/06
Registrant information
Name
Bassim Mohammed Jabbar hatemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3245 2651
Email address
dr.ghorbani@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-28, 1403/04/08
Expected recruitment end date
2024-12-28, 1403/10/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of using dexmedetomidine in inducing and maintaining anesthesia in cardiac surgery patients
Public title
effect of dexmedetomidine in inducing and maintaining cardiac surgery anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged between 18-65 years both sexes male and female Patients under one of these surgery (pump coronary artery bypass surgery- valvular replacement surgery- valvular repair surgery) Informed consent to participate in the study
Exclusion criteria:
Patient with one of these diseases (serious coagulopathy- inflammatory diseases- immunosuppressive and immunomodulatory agents(DMARDs)- with history of arrhythmia- with chronic renal failure- Psychiatric diseases- with history of seizure- with history of rheumatic disorders) Patient uses these medicines (steroids- non-steroidal anti-inflammatory drugs (NSAD) except ASA < ۸۰ mg/day- thrombolytic agent) Patient with more the one surgical procedure at the same time. Alcoholic patient Patient need more than one valve repair
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
We will use a randomized block design with a block size of 4 (each block with two replications for each group) to generate the random assignment sequence. We will use the online site with the URL https://www.sealedenvelope.com to generate the random list. Then, participants are assigned to study groups based on a randomly generated list. Participants will be assigned numbers from 1 to 70 in the order of entering the study, and to conceal the random sequence until the interventions are determined, opaque envelopes containing cards with the type of treatment and the number of participants written on them will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the nature of our study, the patient is unconscious and will not be aware of the type of treatment and medication used.The researcher, who is a doctoral student of anesthesia, will record each of the results of the study on the devices and is not aware of the type of drug used during anesthesia.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Golestan - Gorgan - Kilometer 4 of Gorgan - Sari road - 1st Shast Kola road - Higher Educational Campus of late Falsafi of Golestan University of Medical Sciences - Postal code 4934174515
City
Gorgan
Province
Golestan
Postal code
کد پستی 4934174515
Approval date
2024-06-28, 1403/04/08
Ethics committee reference number
IR.GOUMS.REC.1403.128

Health conditions studied

1

Description of health condition studied
Cardiac surgeries including coronary artery bypass surgery with a pump, valve replacement surgery, and valve repair surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The amount of change in hemodynamic responses (heart rate, blood pressure, mean arterial pressure)
Timepoint
Before and after surgery
Method of measurement
electrocardiogram to measure the heart rate and rhythm monitoring of non-invasive blood pressure, and end-tidal carbon dioxide (capnograph) to measure the paco

Secondary outcomes

1

Description
inflammatory factors (IL1, IL6, IL13, IL18)
Timepoint
before surgery and ۲۴ hours after surgery
Method of measurement
Blood gas analysis

2

Description
lactate level
Timepoint
before, during and after surgery according to following: before induction during induction pre pump, after sternotomy pump۱, pump۲, pump۳, pump off and after closing the ternum.
Method of measurement
Blood gas analysis

3

Description
post-operative recovery time
Timepoint
after surgery
Method of measurement
Retention time in recovery room in hours

Intervention groups

1

Description
Intervention group: 0.5 mcg/kg/hr of dexmedetomidine infusion, midazolam 0.1-0.2 mg/kg/hr, and sufentanil: 3-5 mcg /kg/hr infusion according to patient situation.
Category
Treatment - Drugs

2

Description
Control group: isoflurane 0.4% as an inhalational agent, midazolam 0.1-0.2 mg/kg/hr, and sufentanil: 3-5 mcg /kg/hr infusion according to patient situation.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sayyad Shirazi Hospital Center of Open-heart Surgery
Full name of responsible person
Dr. Mohammad Hadi Tajik
Street address
Shahid Sayyad Shirazi Blvd
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3225 1502
Fax
+98 17 3225 1502
Email
infosayyad@goums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Saeed Gol Firouzi
Street address
Hirkan Boulevard - Central Organization of Golestan University of Medical Sciences and Healthcare Services
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3247 0932
Fax
+98 17 3242 4553
Email
ravabetomoomi@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
All study costs are provided by the student
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
IQ
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Ali Jabbari
Position
Associate Professor of Cardiac Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Sayyad Shirazi Blvd
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3220 2154
Email
amir_a_78@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Ali Jabbari
Position
Associate Professor of Cardiac Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Sayyad Shirazi Blvd
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3220 2154
Email
amir_a_78@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
bassim mohammed jabbar
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Shahid Sayyad Shirazi Blvd
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3220 2154
Email
b.hatemi86.ba@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Correspondence by email with the corresponding author of the article
When the data will become available and for how long
At least 6 months later
To whom data/document is available
All interested researchers
Under which criteria data/document could be used
It will be decided on a case-by-case basis.
From where data/document is obtainable
Correspondence by email with the corresponding author of the article
What processes are involved for a request to access data/document
Correspondence by email with the corresponding author of the article
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