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Trial registered on ANZCTR


Registration number
ACTRN12616000189426
Ethics application status
Approved
Date submitted
12/12/2015
Date registered
12/02/2016
Date last updated
12/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Different Anesthesic Agents on Surgical Site Bleeding During Circumcisions
Scientific title
Effect of Different Anesthesic Agents ( ketamine+midazolam and propofol+fentanyl+lidocaine anesthesia) on Surgical Site Bleeding During Circumcisions
Secondary ID [1] 288138 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
surgical site bleeding during circumcision 297017 0
Condition category
Condition code
Surgery 297615 297615 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of 100 boys (aged 1-8 years) schedule for circumcision were included in the study. Patients were randomly divided into two groups.
In the Group I (n=50), 0.01 mg/kg intravenous midazolam and 2 mg/kg intravenous ketamine were administered only at induction of anaesthesia. In the Group II (n=50), 1 microg/kg intravenous fentanyl, 1 mg/kg intravenous lidocaine, and 2-3 mg/kg intravenous propofol were administered only at induction of anaesthesia and patency of airway was ensured with laryngeal mask airway.
The intraoperative bleeding scale recorded during the procedure to evaluate surgical site bleeding.
Intervention code [1] 293449 0
Treatment: Drugs
Comparator / control treatment
comparator/control group

Group I, receiving 0.01 mg/kg intravenous midazolam and 2 mg/kg intravenous ketamine at induction of anaesthesia
Group II is the control /comparator group, receiving 1 microg/kg intravenous fentanyl, 1 mg/kg intravenous lidocaine, and 2-3 mg/kg intravenous propofol at induction of anaesthesia
Control group
Active

Outcomes
Primary outcome [1] 296854 0
effects of ketamine+midazolam and propofol+fentanyl+lidocaine anesthesia on surgical site bleeding
The intraoperative bleeding scale was used
0= No hemorrhage
1= Slight hemorrhage; no compression via gauze of blood required
2= Slight hemorrhage; occasional compression via gauze required. Surgical field not threatened
3= Slight hemorrhage; frequent compression via gauze required. Hemorrhage threatened surgical field but a few seconds after compression via gauze bleeding was removed
4= Moderate hemorrhage; frequent compression via gauze required. Hemorrhage threatened surgical field directly after gauze compression was removed

The intraoperative bleeding scale defined by Kumari et al. was used

(Kumari I, Naithni U, Bedi V, Gupta S, Gupta R, Bhuie DA. Comparison of clonidine versus midazolam in monitored anesthesia care during ENT surgery– A prospective, double blind, randomized clinical study. Anaesth, Pain&Intensive Care. 2012;16(2):157-64)
Timepoint [1] 296854 0
during circumcision procedures
Secondary outcome [1] 319537 0
bleeding throughout the postoperative
The postoperative bleeding scale was used
0= No hemorrhage
1= Slight hemorrhage: small amount of staining at the incision line
2= Moderate hemorrhage: bleeding stains the dressing
3= Severe hemorrhage: bleeding continues despite of dressing


it was designed specifically for this study.
Timepoint [1] 319537 0
postoperative 3 hours

Eligibility
Key inclusion criteria
- aged 1-8 years
- who admitted to the hospital for circumcision
- American Society of Anesthesiologists (ASA) physical status I-II
Minimum age
1 Years
Maximum age
8 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- who showed contraindications (malignant hyperthermia history, toughness, etc.) under general anesthesia
- who had history of allergy to anesthetic drugs
- known bleeding diathesis; who indicated abnormalities in coagulation tests,
- American Society of Anesthesiologists (ASA) physical status III-IV
.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

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] 7413 0
Turkey
State/province [1] 7413 0
Bursa

Funding & Sponsors
Funding source category [1] 292546 0
Self funded/Unfunded
Name [1] 292546 0
Derya Karasu
Address [1] 292546 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa
Turkey
Country [1] 292546 0
Primary sponsor type
Individual
Name
Derya Karasu
Address
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa
Turkey
Country
Turkey
Secondary sponsor category [1] 291263 0
Individual
Name [1] 291263 0
Canan Yilmaz
Address [1] 291263 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa
Turkey
Country [1] 291263 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294023 0
Yuksek Ihtisas Training and Education Hospital Clinical Research Ethics Committee
Ethics committee address [1] 294023 0
Bursa Yuksek Ihtisas Training and Education Hospital
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa
Turkey
Ethics committee country [1] 294023 0
Date submitted for ethics approval [1] 294023 0
19/09/2014
Approval date [1] 294023 0
01/10/2014
Ethics approval number [1] 294023 0

Summary
Brief summary
Objective: To investigate the effects of ketamine+midazolam and propofol+fentanyl+lidocaine anesthesia on surgical site bleeding during circumcision procedures.

Materials and Methods: A total of 100 boys (aged 1-8 years) schedule for circumcision were included in the study. Patients were randomly divided into two groups. In the Group I (n=50), 0.01 mg/kg intravenous midazolam and 2 mg/kg intravenous ketamine were administered. In the Group II (n=50), 1microg/kg intravenous fentanyl, 1 mg/kg intravenous lidocaine, and 2-3 mg/kg intravenous propofol were administered and patency of airway was ensured with laryngeal mask airway. The intraoperative bleeding scale recorded during the procedure to evaluate surgical site bleeding. Dressing was checked to follow up bleeding throughout the postoperative.

Results: Intraoperative bleeding scores were significantly higher in Group I as compared to Group IIduring circumcision procedures. However, there was no significant difference between the groups in amount of bleeding for postoperative period.

Conclusion: Although intraoperative bleeding scores are significantly higher in ketamine+midazolamgroup compared to propofol+fentanyl+lidocaine group, this kind of bleeding can be easily controlled with appropriate hemostasis. Nevertheless ketamine should be carefully applied in patients with bleeding diathesis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62170 0
Dr Derya Karasu
Address 62170 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa
Turkey
Country 62170 0
Turkey
Phone 62170 0
+90 505 7281175
Fax 62170 0
Email 62170 0
drderyatopuz@gmail.com
Contact person for public queries
Name 62171 0
Dr Derya Karasu
Address 62171 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa
Turkey
Country 62171 0
Turkey
Phone 62171 0
+90 505 7281175
Fax 62171 0
Email 62171 0
drderyatopuz@gmail.com
Contact person for scientific queries
Name 62172 0
Dr Canan Yilmaz
Address 62172 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa
Turkey
Country 62172 0
Turkey
Phone 62172 0
+90 5059045989
Fax 62172 0
Email 62172 0
dr_cnnylmz@yahoo.com

No information has been provided regarding IPD availability
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