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Effects of S-medtomidine infusion on pro- and anti-inflammatory cytokines in pediatric open heart surgery

Protocol summary

Summary
(1) Objectives Assessment of the alterations in vital signs, blood biochemical parameters and inflammatory response in patients undergoing cardiopulmonary bypass premedicated with s-medetomidine or routine anesthesia practice at Rajaei Cardiovascular and Medical Center (2) Design Randomized and double-blinded (3) Setting and conduct Patients candidate for cardiopulmonary bypass surgery were randomly assigned in two groups. Their vital signs and demographic data will be recorded. Plasma sampling will be performed in three different times, before incision, after declamping and 24 hours post-operation. ELISA method will be used for assaying IL-6, IL-8, IL-10 and TNFa markers. (4) Participants including major eligibility criteria Inclusion criteria: informed consent of guardians; weight below or equal to 15 kg; candidate for cardiopulmonary bypass surgery; Congenital heart diseases; Pump time between 1 to 3 hours; operation time between 4 and 5 hours Exclusion criteria: patients’ death; active infection; operation time more than 5 hours and pump time more than 3 hours (5) Intervention 1. s-medetomidine 0.5ug/kg/hr 2. Routine anesthesia practice plus normal saline (6) Main outcome measures (variables) Blood pressure, heart rate, respiratory rate, ICU stay, mechanical ventilation time, cytokines (IL-6, IL-8, IL-10 and TNFa)

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016061927617N2
Registration date: 2016-06-22, 1395/04/02
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-06-22, 1395/04/02
Registrant information
Name
Hamidreza Pazoki-Toroudi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 2708
Email address
pazoki49@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2016-07-15, 1395/04/25
Expected recruitment end date
2016-08-30, 1395/06/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of S-medtomidine infusion on pro- and anti-inflammatory cytokines in pediatric open heart surgery
Public title
Effects of S-medtomidine infusion on pro- and anti-inflammatory cytokines in pediatric open heart surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: informed consent of guardians, age below 6, candidate for elective cardiopulmonary bypass surgery, Pump time between 1 to 3 hours; operation time between 4 and 6 hours Exclusion criteria: infection, coexisting complications, recurrent surgery, deep hypothermia, ejection fraction (EF) below 30%, patients’ death; active infection; operation time more than 5 hours and pump time more than 3 hours, S-medtomidine allergy, administration of S-medtomidine one week before operation
Age
From 6 months old to 6 years old
Gender
Both
Phase
2-3
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
Not used
Assignment
Parallel
Other design features
Patients was unaware of the treatment with s-medtomidine or placebo. Laboratory scientists measuring the serum metabolites were unaware of the study group to which the samples belong. Simple randomization will be used for allocation of participants in intervention and control groups.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of the Iran University of Medical Sciences
Street address
Next to Milad Tower, Hemmat Highway
City
Tehran
Postal code
Approval date
2014-10-23, 1393/08/01
Ethics committee reference number
93-02-30-24854-105519

Health conditions studied

1

Description of health condition studied
congenital heart diseases
ICD-10 code
Q20-Q28
ICD-10 code description
Congenital malformations of the circulatory system

2

Description of health condition studied
Congenital malformations of cardiac septa
ICD-10 code
Q21
ICD-10 code description
Congenital malformations of cardiac septa

3

Description of health condition studied
Congenital malformations of pulmonary and tricuspid valves
ICD-10 code
Q22
ICD-10 code description
Congenital malformations of pulmonary and tricuspid valves

4

Description of health condition studied
Congenital malformations of aortic and mitral valves
ICD-10 code
Q23
ICD-10 code description
Congenital malformations of aortic and mitral valves

Primary outcomes

1

Description
IL-6
Timepoint
Before surgery, after declamp and 24 hours post ICU entrance
Method of measurement
ELISA method on plasma

2

Description
IL-8
Timepoint
Before surgery, after declamp and 24 hours post ICU entrance
Method of measurement
ELISA method on plasma

3

Description
IL-10
Timepoint
Before surgery, after declamp and 24 hours post ICU entrance
Method of measurement
ELISA method on plasma

4

Description
TNFa
Timepoint
Before surgery, after declamp and 24 hours post ICU entrance
Method of measurement
ELISA method on plasma

5

Description
Heart rate
Timepoint
every 3 hours from operation start until 24 hours post-operation
Method of measurement
Vital sign monitoring system

6

Description
blood pressure
Timepoint
every 3 hours from operation start until 24 hours post-operation
Method of measurement
Vital sign monitoring system

7

Description
respiratory rate
Timepoint
every 3 hours from operation start until 24 hours post-operation
Method of measurement
Vital sign monitoring system

Secondary outcomes

empty

Intervention groups

1

Description
Treatment group receives routine anesthesia plus s-medetomidine (0.5 ug/kg/hr)
Category
Treatment - Drugs

2

Description
Control group receives routine anesthesia plus normal saline
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Rajaei Cardiovascular and Medical Center
Full name of responsible person
Farhad Gorjipour
Street address
Niyayesh Cross, Valiasr St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr Seyed-Ali Javad Mousavi
Street address
Next to Milad Tower, Hemmat Highway
City
Tehran
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, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Fazel Gorjipour
Position
Research assistant
Other areas of specialty/work
Street address
Next to Milad Tower, Hemmat highway
City
Tehran
Postal code
Phone
+98 21 8862 2709
Fax
Email
fgorjipour@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Hamidreza Pazoki-toroudi
Position
Associate professor
Other areas of specialty/work
Street address
Next to Milad Tower, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 8862 2697
Fax
Email
hrptoroudi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fazel Gorjipour
Position
Research assistant
Other areas of specialty/work
Street address
Next to Milad Tower, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 8862 2709
Fax
Email
fgorjipour@gmail.com
Web page address

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
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