Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000570280
Ethics application status
Approved
Date submitted
7/07/2009
Date registered
13/07/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of timing of morphine administration during propofol-remifentanil anesthesia on post operative analgesic requirement
Scientific title
Early versus late administration of morphine during propofol-remifentanil anesthesia to compare 24-hour post operative analgesic requirement in patients undergoing an open nephrolithotomy operation
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post operative pain 237232 0
Condition category
Condition code
Anaesthesiology 239550 239550 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intravenous infusion of 0.1 mg/kg morphine over 2 minutes immediately after induction of anesthesia
Intervention code [1] 236921 0
Treatment: Drugs
Comparator / control treatment
intravenous infusion of morphine 0.1 mg/kg over 2 minutes 20-30 minutes before the end of operation(the estimated operation time is about 2 hours)
Control group
Active

Outcomes
Primary outcome [1] 238351 0
Total need to morphine after open nephrolithotomy surgeries to provide acceptable pain score.The patients are asked to rate their pain using a numerical rating scale(0 to 10).The total infused morphine to keep this scale below 3 is measured.
Timepoint [1] 238351 0
24 hours after surgery
Secondary outcome [1] 244779 0
the pain score on awakening in the recovery room. The patients are asked to rate their pain using a numerical rating scale(0 to 10)
Timepoint [1] 244779 0
Awakening in recovery room

Eligibility
Key inclusion criteria
open nephrolithotomy operation
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Drug abuse

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomisation table created by a computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 1871 0
Iran, Islamic Republic Of
State/province [1] 1871 0
Fars

Funding & Sponsors
Funding source category [1] 237269 0
University
Name [1] 237269 0
Shiraz University of Medical Sciences
Country [1] 237269 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Shiraz University of Medical Sciences
Address
Zand Blvd.
71345-1978
Shiraz,Iran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 236759 0
None
Name [1] 236759 0
Address [1] 236759 0
Country [1] 236759 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239370 0
Medical Research Ethics committee of Shiraz University of Medical Sciences
Ethics committee address [1] 239370 0
Ethics committee country [1] 239370 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 239370 0
Approval date [1] 239370 0
30/09/2006
Ethics approval number [1] 239370 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29853 0
Address 29853 0
Country 29853 0
Phone 29853 0
Fax 29853 0
Email 29853 0
Contact person for public queries
Name 13100 0
Farid Zand
Address 13100 0
Department of Anesthesiology
Nemazee Hospital
Nemazee Square
71937-11351
Shiraz
Country 13100 0
Iran, Islamic Republic Of
Phone 13100 0
+98-711-2337636
Fax 13100 0
+98-711-2317082
Email 13100 0
zandf@sums.ac.ir
Contact person for scientific queries
Name 4028 0
Farid Zand
Address 4028 0
Department of Anesthesiology
Nemazee Hospital
Nemazee Square
71937-11351
Shiraz
Country 4028 0
Iran, Islamic Republic Of
Phone 4028 0
+98-711-2337636
Fax 4028 0
+98-711-2317082
Email 4028 0
zandf@sums.ac.ir

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.