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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: TCTR
Last refreshed on: 29 April 2024
Main ID:  TCTR20180109002
Date of registration: 09/01/2018
Prospective Registration: No
Primary sponsor: shahid sadoughi university of medical sciences
Public title: Comparison the effect of morphine and methadone on postoperative pain in opiate addicted patients undergoing CABG
Scientific title: Comparison the effect of morphine and methadone on postoperative pain in opiate addicted patients undergoing CABG
Date of first enrolment: 09/01/2016
Target sample size:
Recruitment status: Completed
URL:  https://www.thaiclinicaltrials.org/show/TCTR20180109002
Study type:  Interventional
Study design:  Randomized  
Phase:  Phase 1/Phase 2
Countries of recruitment
Iran
Contacts
Name: Hossein     Moshtaghion
Address:  shahid sadoughi hospital 353 0098 Iran
Telephone: 00983538224000
Email: moshtaghion@gmail.com
Affiliation:  Shahid Sadoughi university of medical sciences,Yazd, Iran
Name: Hossein     Moshtaghion
Address:  shahid sadoughi hospital 353 0098 Iran
Telephone: 00983538224000
Email: moshtaghion@gmail.com
Affiliation:  Shahid Sadoughi university of medical sciences,Yazd, Iran
Key inclusion & exclusion criteria
Inclusion criteria: 76 opiate-addicted patients with ASA class II and III, aged < 90 years undergoing CABG
Exclusion criteria: history of preoperative renal failure requiring hemodialysis or serum creatinine greater than 2mg / dl, severe hepatic failure, EF less than 30%, pulmonary disease requiring oxygen therapy at home, a disease requiring the use of inotropes or intra-aortic pumps, emergency surgeries and allergy to methadone or intravenous morphine

Age minimum: 0 Years
Age maximum: 90 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Ischemic heart disease (patients undergoing CABG)
postoperative pain, opiate-addicted patients, CABG
postoperative pain, opiate-addicted patients, CABG
Intervention(s)
Active Comparator Drug,Active Comparator Drug
0.15mg / kg of methadone ,0.1mg / kg of morphine
Primary Outcome(s)
mean pain scores At ICU admission 1 hour after ICU admission 2 hours after ICU admission 3 RASS and BPS score,nausia after the operation Questionnaire,vomiting after the operation Questionnaire
Secondary Outcome(s)
Hemodynamic variables ( MAP, O2SAT, HR) at the time of ICU admission, 1, 2, 3, and 4 hours after the operation, and 30 minutes and 2 hours a manomerty, pulse oxymetery, ECG
Secondary ID(s)
Source(s) of Monetary Support
shahid sadoughi university of medical sciences
Secondary Sponsor(s)
shahid sadoughi university of medical sciences,shahid sadoughi university of medical sciences
Ethics review
Status: Request not yet submitted
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed: 09/06/2017
URL:
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