Evaluation and comparison of the preconditioning effect of Remifentanil Vs. Fentanyl on prevalence of early graft dysfunction among patients with liver transplant
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General information
Triple blinded
Double blinded
tripldoubl
1
1
2018-06-16, 1397/03/26
2018-08-17, 1397/05/26
2018-0608-1617 00:00:00
Evaluation of the preconditioning effect of remifentanil-propofol in prevalence of early graft dysfunction in liver transplant patients
Evaluation and comparison of the preconditioning effect of Remifentanil Vs. Fentanyl on prevalence of early graft dysfunction among patients with liver transplant
Evaluation and comparison of the preconditioning effect of remifentanil-propofol inRemifentanil Vs. Fentanyl on prevalence of early graft dysfunction inamong patients with liver transplant patients
بررسی اثر محافظتی داروی رمی فنتانیل در شیوع اختلال کارکرد زودرس ارگان پیوند شده در بیماران پیوند کبد
بررسی و مقایسه اثر محافظتی داروهای رمی فنتانیل و فنتانیل در شیوع اختلال کارکرد زودرس ارگان پیوند شده در بیماران پیوند کبد
بررسی و مقایسه اثر محافظتی دارویداروهای رمی فنتانیل و فنتانیل در شیوع اختلال کارکرد زودرس ارگان پیوند شده در بیماران پیوند کبد
Evaluation of the preconditioning effect of remifentanil-propofol in prevalence of early graft dysfunction in liver transplant patients
Evaluation and comparison of the preconditioning effect of Remifentanil Vs. Fentanyl on prevalence of early graft dysfunction among patients with liver transplant
Evaluation and comparison of the preconditioning effect of remifentanil-propofol inRemifentanil Vs. Fentanyl on prevalence of early graft dysfunction inamong patients with liver transplant patients
بررسی اثر محافظتی داروی رمی فنتانیل در شیوع اختلال کارکرد زودرس ارگان پیوند شده در بیماران پیوند کبد
بررسی و مقایسه اثر محافظتی داروهای رمی فنتانیل و فنتانیل در شیوع اختلال کارکرد زودرس ارگان پیوند شده در بیماران پیوند کبد
بررسی و مقایسه اثر محافظتی دارویداروهای رمی فنتانیل و فنتانیل در شیوع اختلال کارکرد زودرس ارگان پیوند شده در بیماران پیوند کبد
aged 18 to 65 years old
history of hepatopulmonary syndrome
history of portopulmonary hypertension
renal insufficiency (Cr > 1.5 mg/L)
aged 18 to 65 years old
patients who are candidate for liver transplant
aged 18 to 65 years old history of hepatopulmonary syndrome history of portopulmonary hypertension renal insufficiency (Cr > 1.5 mg/L)patients who are candidate for liver transplant
سن ۱۸ تا ۶۵ سال
سابقه هپاتوپولموناری دیس فانکشن
سابقه پورتوپولمونری هایپرتنشن
نارسایی کلیوی (کراتینین >1.5)
سن ۱۸ تا ۶۵ سال
بیماران کاندید عمل جراحی پیوند کبد
سن ۱۸ تا ۶۵ سال سابقه هپاتوپولموناری دیس فانکشن سابقه پورتوپولمونری هایپرتنشن نارسایی کلیوی (کراتینین >1.5)بیماران کاندید عمل جراحی پیوند کبد
allergy to propofol soy beans and egg
donors with cardio-pulmonary arrest or hemodynamic instability with high doses of inotropes (infusion nor epinephrine above µg/min)
cold ischemia time more than 12 hours.
allergy to propofol soy beans and egg
donors with cardio-pulmonary arrest or hemodynamic instability with high doses of inotropes (infusion nor epinephrine above µg/min)
cold ischemia time more than 12 hours.
history of hepatopulmonary syndrome
history of portopulmonary hypertension
renal insufficiency (Cr > 1.5 mg/L)
allergy to propofol soy beans and egg donors with cardio-pulmonary arrest or hemodynamic instability with high doses of inotropes (infusion nor epinephrine above µg/min) cold ischemia time more than 12 hours. history of hepatopulmonary syndrome history of portopulmonary hypertension renal insufficiency (Cr > 1.5 mg/L)
حساسیت به پروپوفول، سویا و تخم مرغ
بیماران دهنده پیوند یا دوزهای بالای اینوتروپ(نوراپی نفرین>15/ ماکروگرم بر کیلوگرم در دقیقه )
زمان سرد بیشتر از ۱۲ ساعت.
حساسیت به پروپوفول، سویا و تخم مرغ
بیماران دهنده پیوند یا دوزهای بالای اینوتروپ(نوراپی نفرین>15/ ماکروگرم بر کیلوگرم در دقیقه )
زمان سرد بیشتر از ۱۲ ساعت.
سابقه هپاتوپولموناری دیس فانکشن
سابقه پورتوپولمونری هایپرتنشن
نارسایی کلیوی (کراتینین >1.5)
حساسیت به پروپوفول، سویا و تخم مرغ بیماران دهنده پیوند یا دوزهای بالای اینوتروپ(نوراپی نفرین>15/ ماکروگرم بر کیلوگرم در دقیقه ) زمان سرد بیشتر از ۱۲ ساعت. سابقه هپاتوپولموناری دیس فانکشن سابقه پورتوپولمونری هایپرتنشن نارسایی کلیوی (کراتینین >1.5)
Patients were randomized according to the charts which was derived from www.randomization.com site.
Patients were randomized according to the charts which was derived from www.randomization.org site.
Patients were randomized according to the charts which was derived from www.randomization.comwww.randomization.org site.
بیماران بر اساس جدول استخراج شده از سایت www.randomization.com تصادفی سازی شده اند.
بیماران بر اساس جدول استخراج شده از سایت www.randomization.org تصادفی سازی شده اند.
بیماران بر اساس جدول استخراج شده از سایت www.randomization.comwww.randomization.org تصادفی سازی شده اند.
Triple blind:The participants,researcher and the Data and Safety Monitoring Board are blinded to the study.
Double blind: participants and assessors of the outcomes are unaware of the study groups
TripleDouble blind:The participants,researcher participants and assessors of the Data and Safety Monitoring Boardoutcomes are blinded tounaware of the study. groups
سه سویه کور : شرکت کنندگان ، محقق وهم کمیته نظارت بر داده ها و ایمنی آنها از نوع مداخله تخصیص داده شده اطلاع ندارند.
دو سویه کور : شرکت کنندگان و فرد ارزیابی کننده مطالعه از نوع مداخله تخصیص داده شده اطلاع ندارند.
سهدو سویه کور : شرکت کنندگان ، محقق وهم کمیته نظارت بر داده ها و ایمنی آنهافرد ارزیابی کننده مطالعه از نوع مداخله تخصیص داده شده اطلاع ندارند.
Secondary outcomes
#1
From day 1 to 7 post-operation
From day 1 to the day of dicharge
From day 1 to 7 post-operationthe day of dicharge
از روز اول و سپس هر روز تا ۷ روز پس از عمل
از روز اول تا زمان ترخیص
از روز اول و سپس هر روز تا ۷ روز پس از عملزمان ترخیص
#2
From day 1 to 7 post-operation
Intra-operative
From day 1 to 7 postIntra-operationoperative
از روز اول و سپس هر روز تا ۷ روز پس از عمل
در طول عمل
از روز اول و سپس هر روز تا ۷ روز پس ازدر طول عمل
#3
From day 1 to 7 post-operation
Intra-operative
From day 1 to 7 postIntra-operationoperative
از روز اول و سپس هر روز تا ۷ روز پس از عمل
در طول عمل
از روز اول و سپس هر روز تا ۷ روز پس ازدر طول عمل
Protocol summary
Study aim
To evaluate the preconditioning of remifentanil Vs. fentanil in prevalence of early graft dysfunction in liver transplant patients
Design
Parallel triple blinded clinical trial
Settings and conduct
100 patients who underwent liver transplantation in the Namazi hospital were randomly allocated into two groups of remifentanil and fentanil and after surgery, all patients were routinely transferred to intensive transplant care unit. Biopsy was done for all the donors’ livers to evaluate the percentage of macro vesicular stenosis.
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA:patients aged 18 to 65 years old and patients with history of hepatopulmonary syndrome; portopulmonary hypertension; renal insufficiency (Cr > 1.5 mg/L).
EXCLUSION CRITERIA: allergy to propofol soy beans and egg; donors with cardio-pulmonary arrest or hemodynamic instability with high doses of inotropes (infusion norepinephrine above µg/min) and cold ischemia time more than 12 hours.
Intervention groups
Remifentanil group: patients received intravenous propofol infusion with doses of 100-150 µg/kg/min as a base of maintenance of anesthesia and remifentanil µg/kg/min 0.1-0.4 infusion (syringe B remifentanil with dilution 40 µg/cc).
Fentanil group :patients received intravenous propofol infusion with doses of 100-150 µg/kg/min as a base of maintenance of anesthesia withµg/kg/min 0.03-0.1 fentanil infusion during maintenance of anesthesia (syringe B, fentanil with dilution 50 µg/cc).
Main outcome variables
Aspartate transaminase (AST), Alanine transaminase (ALT), Alkaline phosphatase (Alkp), prothrombin time (PT), partial thrombin time (PTT) and international normalized ratio (INR) from day 1 to 7 post-operation will be assessed . blood urea nitrogen (BUN), creatinine (Cr), and metabolic acidosis (PH, base excess (BE)). These were evaluated from day 1 to 7 post-operation.
Duration of hospital and ICU stay, ventilator need and extubation time post- operation, cold and warm ischemia time and the received blood products during the operation were recorded
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141009019470N70
Registration date:2018-02-19, 1396/11/30
Registration timing:registered_while_recruiting
Last update:2018-04-07, 1397/01/18
Update count:1
Registration date
2018-02-19, 1396/11/30
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
2018-02-15, 1396/11/26
Expected recruitment end date
2018-08-17, 1397/05/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the preconditioning effect of Remifentanil Vs. Fentanyl on prevalence of early graft dysfunction among patients with liver transplant
Public title
Evaluation and comparison of the preconditioning effect of Remifentanil Vs. Fentanyl on prevalence of early graft dysfunction among patients with liver transplant
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
aged 18 to 65 years old
patients who are candidate for liver transplant
Exclusion criteria:
allergy to propofol soy beans and egg
donors with cardio-pulmonary arrest or hemodynamic instability with high doses of inotropes (infusion nor epinephrine above µg/min)
cold ischemia time more than 12 hours.
history of hepatopulmonary syndrome
history of portopulmonary hypertension
renal insufficiency (Cr > 1.5 mg/L)
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomized according to the charts which was derived from www.randomization.org site.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind: participants and assessors of the outcomes are unaware of the study groups
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
Province
Fars
Postal code
7134844119
Approval date
2016-09-10, 1395/06/20
Ethics committee reference number
IR.SUMS.MED.REC.1395.38
Health conditions studied
1
Description of health condition studied
organ transplant
ICD-10 code
Y83.0
ICD-10 code description
Surgical operation with transplant of whole organ
Primary outcomes
1
Description
Aspartate transaminase (AST), Alanine transaminase (ALT), Alkaline phosphatase (Alkp), prothrombin time (PT), partial thrombin time (PTT) international normalized ratio (INR)
Timepoint
from day 1 to 7 post-operation
Method of measurement
blood sample
Secondary outcomes
1
Description
Blood urea nitrogen (BUN)
Timepoint
From day 1 to 7 post-operation
Method of measurement
Blood sample
2
Description
Duration of hospital and ICU stay
Timepoint
From day 1 to the day of dicharge
Method of measurement
Observation
3
Description
Metabolic acidosis (PH, base excess (BE)
Timepoint
From day 1 to 7 post-operation
Method of measurement
Blood sample
4
Description
Creatinine (Cr)
Timepoint
From day 1 to 7 post-operation
Method of measurement
Blood sample
5
Description
Duration of mechanical ventilation
Timepoint
From day 1 to 7 post-operation
Method of measurement
Observation
6
Description
Extubation time post- operation
Timepoint
From day 1 to 7 post-operation
Method of measurement
Observation
7
Description
Cold and warm ischemia time
Timepoint
Intra-operative
Method of measurement
Observation
8
Description
Amount of received blood products during the operation
Timepoint
Intra-operative
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: In the remifentanil group, patients received intravenous propofol infusion with doses of 100-150 µg/kg/min as a base of maintenance of anaesthesia and remifentanil µg/kg/min 0.1-0.4 infusion (syringe B remifentanil with dilution 40 µg/cc).
Category
Prevention
2
Description
Intervention group: in fentanil group patients received intravenous propofol infusion with doses of 100-150 µg/kg/min as a base of maintenance of anesthesia withµg/kg/min 0.03-0.1 fentanil infusion during maintenance of anesthesia (syringe B, fentanil with dilution 50 µg/cc).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hosptioal
Full name of responsible person
Sanaz Jowkar
Street address
Namazi Hoptioal, Namazi Square
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
sani6684@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
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
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sanaz Jowkar
Position
Anesthesiology Resident/physician
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Bagher Khosravi
Position
Cardio-anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3654 1174
Fax
Email
mbkhosravi@gmail.com
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
Latest degree
Master
Other areas of specialty/work
Street address
5th floor, Mohammad Rasul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available