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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
1
-
Sponsor
-
-
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
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
-
Clinical Study Report
-
Not applicable
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable