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Trial registered on ANZCTR


Registration number
ACTRN12618001034224
Ethics application status
Approved
Date submitted
9/04/2018
Date registered
20/06/2018
Date last updated
5/11/2018
Date data sharing statement initially provided
5/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The early sedation effect of intrathecal morphine administration on adult patients undergoing urogenital surgeries
Scientific title
The early sedation effect of intrathecal morphine administration assessed by intraoperative Bispectral index monitoring and postoperative Ramsey Sedation Scale on adult patients undergoing urogenital surgeries
Secondary ID [1] 290853 0
none
Universal Trial Number (UTN)
U1111-1191-3740
Trial acronym
ITMT (Intrathecal morphine trail)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
urogenital problems 301533 0
sedation 305963 0
Condition category
Condition code
Anaesthesiology 301253 301253 0 0
Anaesthetics
Renal and Urogenital 306616 306616 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients who are between 18 and 65 years of age and referred to urogenital surgeries will be randomly divided into two groups. In the operating room, ECG, non invasive blood pressure, heart rate and Bispectral index monitoring will be applied to all of the patients. The patients will receive 0.03 mg/kg midazolam before spinal anesthesia. During spinal anesthesia, a single dose of 200 microgram intrathecal morphine (0.2 ml) and 13 mg intrathecal bupivacaine will be administered. While in the second group, 0.2 ml intrathecal sodium chloride and 13 mg intrathecal bupivacaine will be applied. The drugs will be prepared in a 5 ml syringe and labeled by an anesthesiologist who will not participate in the study. The Bispectral index scores and peripheral oxygen saturation of the patients will be recorded for one hour in the operating room, then all of the patients will be sent to the post anesthesia caring unit. The patients will be assessed with Ramsey Sedation Scale at every 15 minutes for an hour by a researcher who will be blind to the study groups. Peripheral oxygen saturation levels of the patients will be recorded until the end of 120 minutes.
Intervention code [1] 296794 0
Treatment: Drugs
Comparator / control treatment
All of the patients will receive 0.03 mg/kg midazolam before spinal anesthesia. The control group will receive single dose of 0.2 ml intrathecal sodium chloride and 13 mg intrathecal bupivacaine.
Control group
Active

Outcomes
Primary outcome [1] 304308 0
Early sedation effect of intrathecal morphine assessed by intraoperative Bispectral index monitoring
Timepoint [1] 304308 0
At the 5., 10., 15., 20., 25., 30., 40., 45., 50., 55., 60. (primary timepoint) minute after induction
Primary outcome [2] 305619 0
The early effect of intrathecal morphine on respiratory function as assessed by peripheral oxygen saturation
Timepoint [2] 305619 0
At the 5., 10., 15., 20., 25., 30., 40., 45., 50., 55., 60. (primary timepoint) minute after induction
Secondary outcome [1] 353578 0
Early sedation effect of intrathecal morphine assessed by Ramsey Sedation Scale in the second hour after the induction
Timepoint [1] 353578 0
60th, 75th, 90th, 105th, 120th (secondary timepoint) minute after the induction of anesthesia

Eligibility
Key inclusion criteria
The patients who are between 18-65 years old, ASA status I-II-II and scheduled for urogenital surgeries under spinal anesthesia will be included in the study
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known allergy to morphine or midazolam, liver or renal insufficiency, story of alcohol and substance abuse, story of opioid consumption, pregnancy, patients shorter than 160 cm, obesity, operation time longer than 60 minutes

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis will be performed by the SPSS System (version 22.0, SPSS Inc.,). Values will be expressed as mean±standard deviation or as percentages. The groups will be compared in parametric parameters using Kruskal-Wallis test and in non-parametric parameters using Mann-Whitney U test. The percentage will be calculated in presence and absence group by Pearson's Chi-square test. p< 0.05 will be accepted statistically significant.
Sample size of the study was calculated based on an institutional preliminary study with 10 patients in each group. We considered a 5% reduction in Bi-spectral index to be clinically significant. We determined that 81 patients would be required in each group to demonstrate this difference with a error of 5% and power of 95% at the 60. minute after induction. Allowing for about 10% drop-out rate during the study period, 91 patients were enrolled in each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/07/2018
Date of last participant enrolment
Anticipated
2/07/2018
Actual
2/10/2018
Date of last data collection
Anticipated
3/07/2018
Actual
3/10/2018
Sample size
Target
182
Accrual to date
Final
182
Recruitment outside Australia
Country [1] 9509 0
Turkey
State/province [1] 9509 0
Mugla

Funding & Sponsors
Funding source category [1] 298445 0
Hospital
Name [1] 298445 0
Hacettepe University Hospital
Country [1] 298445 0
Turkey
Primary sponsor type
Individual
Name
Basak Altiparmak
Address
Work organization address: Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 Mentese/MUGLA.
Country
Turkey
Secondary sponsor category [1] 297589 0
None
Name [1] 297589 0
Address [1] 297589 0
Country [1] 297589 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300101 0
Mugla Sitki Koçman University Training and Research Hospital Institutional Ethics Committee
Ethics committee address [1] 300101 0
Ethics committee country [1] 300101 0
Turkey
Date submitted for ethics approval [1] 300101 0
04/05/2018
Approval date [1] 300101 0
05/07/2018
Ethics approval number [1] 300101 0

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

Contacts
Principal investigator
Name 71146 0
Dr Basak ALTIPARMAK
Address 71146 0
Work organization address: Mugla Sitki Koçman Üniversitesi Tip Fakültesi Marmaris yolu üzeri M kapi karsisi, postal code: 48000, Mentese/MUGLA
Country 71146 0
Turkey
Phone 71146 0
+905326726533
Fax 71146 0
Email 71146 0
basak_ugurlu@yahoo.com
Contact person for public queries
Name 71147 0
Basak ALTIPARMAK
Address 71147 0
Work organization address: Mugla Sitki Koçman Üniversitesi Tip Fakültesi Marmaris yolu üzeri M kapi karsisi, postal code: 48000, Mentese/MUGLA
Country 71147 0
Turkey
Phone 71147 0
+905326726533
Fax 71147 0
Email 71147 0
basak_ugurlu@yahoo.com
Contact person for scientific queries
Name 71148 0
Basak ALTIPARMAK
Address 71148 0
Work organization address: Mugla Sitki Koçman Üniversitesi Tip Fakültesi Marmaris yolu üzeri M kapi karsisi, postal code: 48000, Mentese/MUGLA
Country 71148 0
Turkey
Phone 71148 0
+905326726533
Fax 71148 0
Email 71148 0
basak_ugurlu@yahoo.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
The data will be available on request immediately following publication and no end-date
Available to whom?
only researchers who provide a methodologically sound proposal,
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator


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.