Objective: Clinical trial of the effect of intravenous analgesia by paracetamol compared to fentanyl in patients undergo coronary heart bypass surgery. Design of the study: randomization using random permuted blocks, convenience sampling, double-blind, single-center, phase II trial. Study population: all patients with stage 5 of renal failure. Main inclusion criteria: pre-operation ejection fraction above 30%; class one to three of ASA; no simultaneous heart valves involvement; no need of intra-aort pump usage during the operation. Main exclusion criteria: positive history of sensitivity to study drugs; uncontrolled systemic disease such as diabetes; addiction to alcohol and drugs; positive history of psychologic disease and depression; asthma and other hypersensitivity reactions; fracture of sternum and ribs intraoperation; pre-operative liver enzymes rising higher than two folds; other chest pain causes other than coronary arteries; presence of neurologic signs and symptoms; any type of consciousness impairment pre-operation. Sample size: 160. Interventions: First group: Bolus intravenous infusion of 50 microgram fentanyl followed by pump infusion of 10 microgram per cc in speed of 4 cc in hour; second group: bolus intravenous infusion of 15 microgram per kilogram of paracetamol followed by pump infusion of 25 micrograms per cc in speed of 4 cc in hour. Intervention time: after the operation and before being transferred to ICU.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121131351N1
Registration date:2017-01-27, 1395/11/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-27, 1395/11/08
Registrant information
Name
Yalda Moeini
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5799
Email address
yaldamoini@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Expected recruitment start date
2015-10-02, 1394/07/10
Expected recruitment end date
2017-02-28, 1395/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of intravenous analgesia by paracetamol compared to fentanyl in patients undergo coronary heart bypass surgery
Public title
Comparison the effect of intravenous analgesia by paracetamol versus fentanyl in patients undergo coronary heart surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Main inclusion criteria: pre-operation ejection fraction above 30%; class one to three of ASA; no simultaneous heart valves involvement; no need of intra-aort pump usage during the operation. Main exclusion criteria: positive history of sensitivity to study drugs; uncontrolled systemic disease such as diabetes; addiction to alcohol and drugs; positive history of psychologic disease and depression; asthma and other hypersensitivity reactions; fracture of sternum and ribs intraoperation; pre-operative liver enzymes rising higher than two folds; other chest pain causes other than coronary arteries; presence of neurologic signs and symptoms; any type of consciousness impairment pre-operation.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Zahedan University of Medical Sciences
Street address
Ethics Committee of Zahedan University of Medical Sciences, Zahedan University of Medical Sciences, Dr.Hesabi Square, Zahedan
City
Zahedan
Postal code
Approval date
2015-09-20, 1394/06/29
Ethics committee reference number
IR.ZAUMS.REC.1394.238
Health conditions studied
1
Description of health condition studied
Coronary artery bypass
ICD-10 code
I25, I25.0
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Postoperation pain
Timepoint
Two houres, four houres, eight houres, 12 houres and 24 houres after surgery
Method of measurement
VAS Criteria
2
Description
Mean arterial pressure
Timepoint
Up to 24 hours after surgery in intervals of every 4 hours
Method of measurement
Millimeter of mercury
3
Description
Heart rate
Timepoint
Up to 24 hours after surgery in intervals of every 4 hours
Method of measurement
Beats in minute
Secondary outcomes
empty
Intervention groups
1
Description
First group: Bolus intravenous infusion of 50 microgram fentanyl followed by pump infusion of 10 microgram per cc in speed of 4 cc in hour
Category
Treatment - Drugs
2
Description
Second group: Bolus intravenous infusion of 15 microgram per kilogram of paracetamol followed by pump infusion of 25 microgram per cc in speed of 4 cc in hour