Protocol summary

Study aim
Comparison of the effect of target control injection (TCI) of anesthetic with conventional method on creatinine level of patients with renal impairment in open heart surgery
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 66 patients. In order to randomize, the block randomization method will be used.
Settings and conduct
In this study, all patients needed open heart surgery with renal impairment who referred to Rajai Hospital will be enrolled. Patients will be randomly divided into 3 groups based on 6 blocks. The sample size for each study group is 22. A total of 66 patients will be examined. Patients, surgeon and data analyzer will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who are candidates for open heart surgery who have creatinine greater than 1.5 mg / dl; patients over 18 years. Exclusion criteria: Patients over 70 years; pregnancy.
Intervention groups
First intervention group: For anesthesia of patients with targeted controlled injection, Remy Fentanyl with a dose of 0.5 - 1 μ/kg, proponol with a dose of 2 - 2.5 mg/kg and then Atra with a dose of 0/15 - 0/2 mg/kg will be used. Second intervention group: for anesthesia of patients from Midazolam with a dose of 0.2 - 0.4 mg/kg, Fentanyl with a dose of 2-20 μg/kg and Atra with a dose of 0.005 - 0.01 mg/kg/min Will be infused continuously. Control group: For patients undergoing conventional anesthesia, Remi Fentanyl at a dose of 0.5-1 μ/kg, Proponol at a dose of 2 -2/5 mg/kg, and then Atra at a dose of 0.15 - 0.2 mg/kg will be used.
Main outcome variables
Total dose of anesthesia; Creatinine levels; Duration of hospitalization in the ICU

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151003024317N11
Registration date: 2020-07-11, 1399/04/21
Registration timing: prospective

Last update: 2020-07-11, 1399/04/21
Update count: 0
Registration date
2020-07-11, 1399/04/21
Registrant information
Name
Mahdi Rezai
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8868 6772
Email address
rezaei.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-20, 1399/04/30
Expected recruitment end date
2021-03-15, 1399/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of target control injection (TCI) of anesthetic with conventional method on creatinine level of patients with renal impairment in open heart surgery
Public title
The Effect of Target Control Infusion (TCI) on the Creatine Level of Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for open heart surgery who have creatinine greater than 1.5 mg / dl Patients over 18 years old
Exclusion criteria:
Patients over 70 years Pregnancy
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to tree groups. In order to randomize, a random block method will be used. For this purpose, we formed blocks of size 6. In each block, 2 individuals will be in intervention group 1, 2 individuals will be in intervention group 2 and 2 will be in control group. A total of 11 blocks will be considered for the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Surgeons and patients will be kept blind and unaware of the type of anesthesia. Patients will be aware that they will be randomly assigned to one of three treatment groups, but will be unaware of which treatment will be provided in that group. Patients will be assigned to one of three groups using random number tables. The surgeon also knows that patients will be anesthetized in three different ways, but will not know which procedure will be performed for each patient. The data collection officer, analyst, outcome assessor and data safety and Data Safety and Monitoring Committee will collect and analyze information based on groups 1, 2 and 3 and will not be aware of the type of treatment provided in the groups. They will be kept blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-05-16, 1399/02/27
Ethics committee reference number
IR.IUMS.FMD.REC.1399.130

Health conditions studied

1

Description of health condition studied
Renal impairment in open heart surgery
ICD-10 code
I97.1
ICD-10 code description
Other functional disturbances following cardiac surgery

Primary outcomes

1

Description
Total dose of anesthesia
Timepoint
After surgery
Method of measurement
Based on patient records

2

Description
Creatinine levels
Timepoint
During surgery, After surgery, 24 hours after surgery
Method of measurement
Based on patient records

3

Description
Duration of hospitalization in the ICU
Timepoint
During patient discharge
Method of measurement
Based on patient records

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: For anesthesia of patients by targeted controlled injection, Remy Fentanyl with a dose of 0.5-1 μ/kg (manufacturer: NORMON,SA(spain)), proponol with a dose of 2 - 2.5 mg/kg (manufacturer: BRUN/B) and Cis Atracurium (Manufacturer: Behin Tamin Rosa Mod Co.) at a dose of 0.15-0.2 mg/kg will be injected. Then, depending on the depth of anesthesia, the drug will injected and whenever the number of BIS reaches between 40 and 60, the patient will intubated and in order to maintenance anesthesia, proponol with a dose of 2-3 μ/ml in patients over 50 years or 3-4 μ/ml in Patients under 50 years, Remy Fentanyl with a dose of 3-6 ng/ml in patients over 50 years and 5-8 ng/ml in patients less than 50 years and finally Cis Atracurium with a dose of 3 μ/ kg/min will be prescribed with TCI technique.
Category
Treatment - Drugs

2

Description
Second intervention group: for anesthesia of patients from Midazolam with a dose of 0.2 - 0.4 mg/kg (manufactured by Exir Company), Fentanyl with a dose of 2-20 μg/kg (manufactured by Caspian Tamin Rasht Factory) and Atracurium with a dose of 0.005 - 0.01 mg/kg/min (manufactured by Abu Reihan Company) Will be infused continuously.
Category
Treatment - Drugs

3

Description
Control group: For patients undergoing conventional anesthesia, Remy Fentanyl with a dose of 0.5-1 μ/kg (manufacturer: NORMON,SA(spain)), proponol with a dose of 2 - 2.5 mg/kg (manufacturer: BRUN/B) and Cis Atracurium (Manufacturer: Behin Tamin Rosa Mod Co.) at a dose of 0.15-0.2 mg/kg will be injected. Then, depending on the depth of anesthesia, the drug will injected and whenever the number of BIS reaches between 40 and 60, the patient will intubated and in order to maintenance anesthesia, proponol with a dose of 2-3 μ/ml in patients over 50 years or 3-4 μ/ml in Patients under 50 years, Remy Fentanyl with a dose of 3-6 ng/ml in patients over 50 years and 5-8 ng/ml in patients less than 50 years and finally Cis Atracurium with a dose of 3 μ/ kg/min will be injected with a regular pump.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Nazanin Ahmadi
Street address
Rajaie Cardiovascular Medical and Research Center, Next to Mellat Park, Vali-e-Asr St.
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
Email
info@rhc.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Motevallian
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mohsen Ziyaei Fard
Position
Associate Professor of Anesthesia and Special Care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Rajaie Cardiovascular Medical and Research Center, Next to Mellat Park, Vali-e-Asr St.
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
mziyaeifard@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohsen Ziyaei Fard
Position
Associate Professor of Anesthesia and Special Care
Latest degree
Specialist
Other areas of specialty/work
Biochemistry
Street address
Rajaie Cardiovascular Medical and Research Center, Next to Mellat Park, Vali-e-Asr St.
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
mziyaeifard@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohsen Ziyaei Fard
Position
Associate Professor of Anesthesia and Special Care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Rajaie Cardiovascular Medical and Research Center, Next to Mellat Park, Vali-e-Asr St.
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
mziyaeifard@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...