Influence of Dexmedetomidine on Pulmonary Hypertensive Crisis and Arrhythmias and Extubation Time in Cardiac Surgery Patients with Left to Right Shunt and Severe PH
Objective: to evaluate the effect of dexmedetomidine on pulmonary hypertension and irregular heartbeat and extubation time in patients after heart surgery with left to right shunt and severe pulmonary hypertension.
Study design: prospective randomized study.
Inclusion criteria: children under one year old who are undergoing elective cardiac surgery for Ventricular septal defect, severe pulmonary hypertension and left to right shunt.
Exclusion criteria: severe hepatic failure; renal failure (Cr ≥1 / 5); heart block; primary hypotension; bradycardia.
Method: 66 patients under one-year-old with the Ventricular septal defect or left to right shunt and severe pulmonary hypertension randomly divided into 2 groups.
In dexmedetomidine group from the beginning of cardiopulmonary bypass in addition to the common drugs like Milrinone and Sildenafil, intravenous infusion of dexmedetomidine will be administered (0.5 5µg/kg/hr.) and continued for 24 hours.
While, Dexmedetomidine was not used in control group .
Pulmonary hypertension, arrhythmia and extubation time are recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016081619470N40
Registration date:2017-04-19, 1396/01/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-04-19, 1396/01/30
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Influence of Dexmedetomidine on Pulmonary Hypertensive Crisis and Arrhythmias and Extubation Time in Cardiac Surgery Patients with Left to Right Shunt and Severe PH
Public title
Influence of Dexmedetomidine on Pulmonary Hypertensive Crisis and Arrhythmias and Extubation Time in Cardiac Surgery Patients with Left to Right Shunt and Severe PH
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All children under one year old undergoing elective surgery and have severe pulmonary hypertension and left to right shunt.
Exclusion criteria: severe hepatic failure, renal failure (Cr ≥1 / 5); heart block; primary hypotension, bradycardia.
Age
To 1 year old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2014-08-20, 1393/05/29
Ethics committee reference number
IR.SUMS.REC.1394.128
Health conditions studied
1
Description of health condition studied
Congenital heart disease
ICD-10 code
Q24
ICD-10 code description
Other congenital malformations of heart
Primary outcomes
1
Description
arrhythmias
Timepoint
At 0,6,12, 24, 48, 72hours during surgery and after surgery in the ICU.
Method of measurement
EKG monitoring
Secondary outcomes
1
Description
pulmonary artery pressure
Timepoint
After surgery and after pulmonary artery catheter insertion in the intensive care unit.
Method of measurement
pulmonary artery catheter
2
Description
Patient's extubation time
Timepoint
After transferring patient to the intensive care unit.
Method of measurement
observasion
Intervention groups
1
Description
In dexmedetomidine group apart from common drugs used to manage anesthesia and pulmonary hypertension in patients with severe pulmonary hypertension like Milrinone and Sildenafil, dexmedetomidine began to be used in intravenous infusion with the dose of 0.5 5µg/kg/hr. from the beginning of cardiopulmonary bypass and continued for 24 hours.
Category
Treatment - Drugs
2
Description
In the control group apart from common drugs used to manage anesthesia and pulmonary hypertension in patients with severe pulmonary hypertension like Milrinone and Sildenafil, Dexmedetomidine was not used in intravenous infusion.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahi Faghihi Hospital
Full name of responsible person
Bahdor Azizi
Street address
Shahid Faghihi Hospital, Zand Street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Bahador Azizi
Position
cardiovascular perfusionist
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
bahadorazizi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz Universiy of Medical Sciences
Full name of responsible person
Dr Bahram Ghasemzadeh
Position
Cardio-surgon
Other areas of specialty/work
Street address
Namazi Hospital, Namazi square
City
Shiraz
Postal code
Phone
+98 71 3626 8088
Fax
Email
ghasemzadeh@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
MS in english teaching ,BS in anesthesia/English Consultant
Other areas of specialty/work
Street address
5th floor, Mohammad Rasul Allah Research Tower, Khalili Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)