UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019389 |
|---|---|
| Receipt number | R000022424 |
| Scientific Title | Evaluation of the Effect of intravenous paracetamol on perioperative pain in coronary artery bypass graft surgery |
| Date of disclosure of the study information | 2015/11/16 |
| Last modified on | 2015/10/17 00:39:17 |
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Basic information
Public title
Evaluation of the Effect of intravenous paracetamol on perioperative pain in coronary artery bypass graft surgery
Acronym
Intravenous paracetamol and surgical pain
Scientific Title
Evaluation of the Effect of intravenous paracetamol on perioperative pain in coronary artery bypass graft surgery
Scientific Title:Acronym
Intravenous paracetamol and surgical pain
Region
| Asia(except Japan) |
Condition
Condition
Perioperative pain in coronary artery bypass graft surgery
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1- Effects of paracetamol on perioperative pain
Basic objectives2
Others
Basic objectives -Others
1- perioperativr hemodynamic chakges
2- fever, nasea, vomiting
3- liver enzyme
4- opioid and sedative requirement
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Preemptive administration of paracetamol and continue to be administered in the postoperative treatment with prescription of opioids drugs will improved quality of pain control after coronary artery bypass surgery.
Key secondary outcomes
1- the potency is not enough to reduce the need for narcotics and sedatives drugs and eliminate their side effects.
2- no additional liver damages
3- Hemodynamic stability
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In paracetamol group 15 minutes before induction of anesthesia 1 g intravenous paracetamol in 50 cc normal saline solution was infused to the patient within 15 minutes.
Next dose of paracetamol was 1 g which was infused intravenously over 15 minutes within 6-4 hours after the first dose, so that the injection time was during the last 20 minutes of surgery.
Then subsequent doses of paracetamol, every 6 hours for 3 days was injected in intensive care at a rate of 1 g.
Interventions/Control_2
In the control group at all stages of paracetamol injection instead of paracetamol equal volume of normal saline was used.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | < |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria for the study were: undergoing elective surgery CABG, the individual agreement to participate in the study, age 40 to 70 years, not having liver failure (Serum bilirubin greater than 1.8 mg per deciliter and aspartate and alanine aminotransfraz more than 1.5 times of the upper limit of normal), not having renal failure (serum creatinine greater than 2 mg per deciliter), not addictive to opioid drugs and psychotropic substances, and having cardiac ejection fraction greater than 30%.,
Key exclusion criteria
Excessive bleeding after surgery (more than 150 ml for the first two hours), having other surgeries in addition to coronary artery bypass surgery such as repair or replacement of heart valves, repeated surgery, and the need for aortic balloon support.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mojtaba Mansouri |
Organization
Isfahan university of medical sciences
Division name
Anesthesiology and Critical Care Research Center, Department of Anesthesiology
Zip code
Address
Hezar Jarib st., Isfahan University of Medical Sciences, Isfahan, Iran.
TEL
+81-0989133101348
mansouri@med.mui.ac.ir
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mojtaba mansouri |
Organization
Isfahan university of medical sciences
Division name
Anesthesiology and Critical Care Research Center, Department of Anesthesiology
Zip code
Address
Hezar Jarib st., Isfahan University of Medical Sciences, Isfahan, Iran.
TEL
+81-098-9133101348
Homepage URL
mansouri@med.mui.ac.ir
Sponsor or person
Institute
Isfahan university of medical sciences
Institute
Department
Personal name
Funding Source
Organization
---
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Isfahan university of medical sciences
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
| 2014 | Year | 07 | Month | 03 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 16 | Day |
Date analysis concluded
| 2014 | Year | 08 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 17 | Day |
Last modified on
| 2015 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022424
