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Trial registered on ANZCTR


Registration number
ACTRN12616000855426
Ethics application status
Approved
Date submitted
25/05/2016
Date registered
29/06/2016
Date last updated
29/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of anesthetic management using bispectral index monitorization on postoperative agitation in pediatric anesthesia
Scientific title
The effect of anesthetic management using bispectral index monitorization on postoperative agitation in pediatric anesthesia
Secondary ID [1] 289249 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative agitation 298825 0
Condition category
Condition code
Anaesthesiology 298884 298884 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The standard anesthesia protocol will consist of oral premedication with midazolam (0.5 mg/kg) followed by an inhaled induction with sevofurane 8% and placement of a peripheral IV cannula. Fentanyl 1 to 1.5 microgram/kg and rocuronium 0.5 to 0.6 mg/kg will be given before intubation. After intubation, the patients will be allocated into two groups randomly. Maintenance of anesthesia will be accomplished by titrating sevofurane (between 0.5% to 3.0%) in a background of 50% air in O2. The patients in Group 1 will receive routine anesthasia while the ones in Group 2 will receive anesthesia in an adjusted manner, with the BIS values between 45-55. Patients in Group 2 will be monitored with use of bispectral index and the level of anesthesia will be adjusted according to the results of the measurements. BIS monitorization will be carried out by the same anesthetist with minimum 5 years’ experience in pediatric anaesthesia, Bispectral Index Scale monitoring is used to prevent intraoperative awakening or awareness and to provide an accurate titration of the anesthesia agents to promote faster recovery from anesthesia. BIS monitoring involves for participants, small monitoring device placed across participant's forehead throughout procedure. Many clinical studies have shown that the administration of anesthetic agents under the guidance of BIS monitoring
has allowed for more effective drug use, faster recovery from anesthesia, shorter time to extubation, and better recovery.. The BIS is displayed number between 0 and 100, with 45–55 being suitable for surgical anesthesia. Treating anaesthetist decides based on their clinical discretion how and by how much anaesthesia will be titrated if the BIS value drops out of the range of 45-55 Only patints in group 2 will be assessed with BIS.
Intervention code [1] 294845 0
Prevention
Intervention code [2] 295117 0
Treatment: Devices
Comparator / control treatment
Deepness of anesthesia will be monitored traditionally for patients in Group 1, regarding the clinical findings (blood pressure, heart rate, pupil diameter, absence or presence of spontaneous respiration).
Control group
Active

Outcomes
Primary outcome [1] 298428 0
Agitation, assessed using Faces, Legs, Activity, Cry and Consolability (FLACC)
Timepoint [1] 298428 0
The time period for development of agitations,
FLACC will be assessed at 1st, 5th, 10th, 15th, 30th, 45th and 60th minutes after completion of anesthesia.
Primary outcome [2] 298576 0
Behavioral Pain Assessment Scale
Timepoint [2] 298576 0
Behavioral Pain Assessment Scale will be assessed at 1st, 5th, 10th, 15th, 30th, 45th and 60th minutes after completion of anesthesia.
Primary outcome [3] 298578 0
Postoperative Agitation Scale
Timepoint [3] 298578 0
Postoperative Agitation Scale will be assessed at 1st, 5th, 10th, 15th, 30th, 45th and 60th minutes after completion of anesthesia.
Secondary outcome [1] 324096 0
Total time to stay in postoperative care unit will be recorded by using review of patient medical records.
Timepoint [1] 324096 0
Total time to stay in postoperative care unit will be recorded at discharge from postoperative care unit.

Eligibility
Key inclusion criteria
The patients who will undergo elective surgery under general anesthesia
Minimum age
2 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who undergo adenoidectomy and toncillectomy
Patients with mental retardation or neurologic disorders

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 7900 0
Turkey
State/province [1] 7900 0
Afyonkarahisar

Funding & Sponsors
Funding source category [1] 293675 0
University
Name [1] 293675 0
Afyon Kocatepe University
Country [1] 293675 0
Turkey
Primary sponsor type
Individual
Name
Serdar Kokulu
Address
Afyon Kocatepe University, School of Medicine, Department of Anesthesiology and Reanimation
Afyon Kocatepe Universtitesi Tip Fakültesi Ali Cetinkaya Kampusu Afyon-Izmir karayolu 8.km 03200 Afyonkarahisar Turkey
Country
Turkey
Secondary sponsor category [1] 292508 0
None
Name [1] 292508 0
Address [1] 292508 0
Country [1] 292508 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295112 0
Isparta Suleyman Demirel University
Ethics committee address [1] 295112 0
Ethics committee country [1] 295112 0
Turkey
Date submitted for ethics approval [1] 295112 0
Approval date [1] 295112 0
28/03/2016
Ethics approval number [1] 295112 0

Summary
Brief summary
One hundred patients (aging 2-7 years) to undergo elective surgery under general anesthesia will be included in the study. The patients will be randomly allocated into two groups. Both patients will be anesthetised using standard methods. In Group 1, deepness of the anesthesia will be measured regarding the heart rate and arterial blood pressure. Doses for inhalation anesthetics will be adjusted according to the vital findings of the patients. In Group 2, deepness of anesthesia will be determined using Bispectral Index monitorization (BIM). Doses for inhalation anesthetics will be determined according to the findings obtained in BIM. Postoperative agitation levels of the patients will be assessed using the Face, Legs, Activity, Cry and Consolability (FLACC) scale and the Postoperative Agitation Scale.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65966 0
A/Prof SERDAR KOKULU
Address 65966 0
Afyon Kocatepe University School of Medicine Department of Anesthesiology and Reanimation
Afyon Kocatepe Universitesi Tip Fakültesi Ali Cetinkaya Kampusu Afyon-Izmir karayolu 8.km 03200 Afyonkarahisar Turkey
Country 65966 0
Turkey
Phone 65966 0
+90 272 2345112
Fax 65966 0
Email 65966 0
[email protected]
Contact person for public queries
Name 65967 0
A/Prof Serdar Kokulu
Address 65967 0
Afyon Kocatepe University School of Medicine Department of Anesthesiology and Reanimation
Afyon Kocatepe Universitesi Tip Fakültesi Ali Cetinkaya Kampusu Afyon-Izmir karayolu 8.km 03200 Afyonkarahisar Turkey
Country 65967 0
Turkey
Phone 65967 0
+90 272 234 5112
Fax 65967 0
Email 65967 0
[email protected]
Contact person for scientific queries
Name 65968 0
A/Prof Serdar Kokulu
Address 65968 0
Afyon Kocatepe University School of Medicine Department of Anesthesiology and Reanimation
Afyon Kocatepe Universtitesi Tip Fakültesi Ali Cetinkaya Kampusu Afyon-Izmir karayolu 8.km 03200 Afyonkarahisar Turkey
Country 65968 0
Turkey
Phone 65968 0
+90 272 2345112
Fax 65968 0
Email 65968 0
[email protected]

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
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