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Trial registered on ANZCTR


Registration number
ACTRN12617000859381
Ethics application status
Approved
Date submitted
9/05/2017
Date registered
9/06/2017
Date last updated
9/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of effects of anesthetic selection in circumcision operations performed with different anesthetics
Scientific title
Comparison of effects of anesthetic selection on recovery in circumcision operations performed with ketamine-midazolam and ketamine-propofol anesthesia
Secondary ID [1] 291865 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
healthy patients 303146 0
Condition category
Condition code
Anaesthesiology 302595 302595 0 0
Anaesthetics
Surgery 302732 302732 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
first group: ketamin(2mg/kg)+midazolam(0,05mg/kg) were administered intravenously (single injection)-injections were done 3 mnutes before surgery start.
second group: ketamin(1mg/kg) + propofol(3mg/kg) were adminsitered intravenously (single injection) for circumcision operation,injections were done 3 mnutes before surgery start.
recovery from anesthesia according to hypnotic selection was assessed
Intervention code [1] 297982 0
Treatment: Drugs
Comparator / control treatment
no control group, Two drug combinations were compared
Control group
Active

Outcomes
Primary outcome [1] 302009 0
recovery times were compared wtih ketamine-midazolam and ketamine-propofol group.
start time of spontaneus ventilation and eye opening with verbal stimulus time were measured with minute(s).
Timepoint [1] 302009 0
45 minutes after surgery ended
Secondary outcome [1] 334512 0
none
Timepoint [1] 334512 0
none

Eligibility
Key inclusion criteria
Parental consent
5-12 years children
ASA I and II physical status
Elective circumcision surgery
Minimum age
5 Years
Maximum age
12 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
if parental consent in not present
ASA III or worst physical status
Emergency procedures

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
SPSS software version 21.0 (IBM'Registered Trademark' SPSS'Registered Trademark' Statistics V21.0) was used for statistical analysis.
Chi-square test was used for categorical data and other personal variables.
(statistical significance p= 0.05)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8876 0
Turkey
State/province [1] 8876 0
konya

Funding & Sponsors
Funding source category [1] 296366 0
Hospital
Name [1] 296366 0
konya training and education hospital
Address [1] 296366 0
konya training and education hospital
Hacisaban Mahallesi Yeni Meram Cd No:97, 42090 Meram/Konya
Country [1] 296366 0
Turkey
Primary sponsor type
Hospital
Name
konya training and education hospital
Address
konya training and education hospital
Hacisaban Mahallesi Yeni Meram Cd No:97, 42090 Meram/Konya
Country
Turkey
Secondary sponsor category [1] 295307 0
None
Name [1] 295307 0
Address [1] 295307 0
Country [1] 295307 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297603 0
meram medicine faculty committe of ethics
Ethics committee address [1] 297603 0
Yunus Emre Mahallesi, 42080 Meram/Konya
Ethics committee country [1] 297603 0
Turkey
Date submitted for ethics approval [1] 297603 0
28/12/2015
Approval date [1] 297603 0
16/12/2016
Ethics approval number [1] 297603 0
14567952-050/246

Summary
Brief summary
Objective:To compare the therapeutic effects of ketamine plus midazolam or ketamine plus propofol on analgesia, sedation, recovery time, side effects in premedicated children with midazolam who are prepared circumcision operation.Methods: 80 American Society of Anaesthesiologists physical status I---II children, aged between 5 and 12 years, undergoing circumcision operations under sedation were recruited according to a randomize and double-blind institutional review board-approved protocol. Patients were randomized into two groups via sealed envelope assignment. Both groups were administered of midazolam 0.04 mg/kg intravenously in the presence of parents in the pre-operative holding area. Patients were induced with midazolam-ketamine in Group I or ketamine-propofol in Group II. Results: In the between-group comparisons, age, weight, no difference was observed (p > 0.05). Recovery was faster in ketamine-midazolam group (p < 0.05). Conclusion: midazolam-ketamine provided faster recovery than ketamine-propofol in pediatric circumcision operations. We did not observe significant complications during sedation in these two groups. Therefore, ketomine-midazolam appears to provide a faster recovery for circumcision operation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74558 0
Dr eyup aydogan
Address 74558 0
Konya Training and Research Hospital
Hacisaban Mahallesi, Yeni Meram Cd. No:97, 42090 Meram/Konya
Country 74558 0
Turkey
Phone 74558 0
+90 332 221 00 00-2250
Fax 74558 0
Email 74558 0
eypaydogan@hotmail.com
Contact person for public queries
Name 74559 0
Dr eyup aydogan
Address 74559 0
Konya Training and Research Hospital
Hacisaban Mahallesi, Yeni Meram Cd. No:97, 42090 Meram/Konya
Country 74559 0
Turkey
Phone 74559 0
+90 332 221 00 00-2250
Fax 74559 0
Email 74559 0
eypaydogan@hotmail.com
Contact person for scientific queries
Name 74560 0
Dr eyup aydogan
Address 74560 0
Konya Training and Research Hospital
Hacisaban Mahallesi, Yeni Meram Cd. No:97, 42090 Meram/Konya
Country 74560 0
Turkey
Phone 74560 0
+90 332 221 00 00-2250
Fax 74560 0
Email 74560 0
eypaydogan@hotmail.com

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary