Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000963224
Ethics application status
Approved
Date submitted
4/04/2018
Date registered
7/06/2018
Date last updated
18/12/2018
Date data sharing statement initially provided
18/12/2018
Date results information initially provided
18/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Sugammadex Effects on Children's Awakening from Adenotonsillectomy Surgery
Scientific title
The Effects Of Sugammadex On Emergence Agitation In Children Undergoing Adenotonsillectomy
Secondary ID [1] 294372 0
none
Universal Trial Number (UTN)
U1111-1211-0577
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
emergence agitation 307104 0
Condition category
Condition code
Anaesthesiology 306213 306213 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Using 2 mg/kg single dose sugammadex as an intravenous formula at the end of the surgery . No strategies to monitor about the drug
Intervention code [1] 300676 0
Treatment: Drugs
Comparator / control treatment
Neostigmine group It will be administered at the end of the surgery 50 mcgr/kg intravenously single dose only. No strategies to monitor about the drug
Control group
Active

Outcomes
Primary outcome [1] 305227 0
patients with PAED score>=10 were defined as agitated
proportion of participants with a PAED score>=10 will be certain at the end of the clinical trial.
(PAED: paediatric anaesthesia emergence delirium)
Timepoint [1] 305227 0
first 15 minutes in the recovery room
Primary outcome [2] 305229 0
patients with agitation scale (AS)>3 were defined as agitated
Number of participants with an agitation scale (AS) score greater than 3 will be certain at the end of the clinical trial
Timepoint [2] 305229 0
first 15 minutes in the recovery room
Secondary outcome [1] 344541 0
laryngobronchospasm risk after extubation. It will be evaluated with pulse oxymeter decreasing and chest physical examination as stridor and rales.
Number of participants wit laryngobronchospasm will be certain at the end of the clinical trial.
Timepoint [1] 344541 0
at the time of extubation and the first 15 minutes in the recovery room

Eligibility
Key inclusion criteria
90 children between 3-15 years who had no other additional disease (ASA1) scheduled to undergo adenotonsillectomy
Minimum age
3 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA 2 and over
Need for a second surgery because of bleeding
drug allergies
any respiratory tract infection

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)
allocation will be concealed by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Proportion test was used to compare the agitation rates of the two groups.
P<0.05 values were considered statistically significant.
R Core Team (2016) was used for all the statistical analyzes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/06/2018
Actual
7/06/2018
Date of last participant enrolment
Anticipated
13/07/2018
Actual
30/07/2018
Date of last data collection
Anticipated
13/07/2018
Actual
30/07/2018
Sample size
Target
90
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 10225 0
Turkey
State/province [1] 10225 0
Mugla

Funding & Sponsors
Funding source category [1] 299013 0
Hospital
Name [1] 299013 0
Mugla Sitki Kocman University Training and Research Hospital
Country [1] 299013 0
Turkey
Primary sponsor type
Individual
Name
Semra Gumus Demirbilek
Address
Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon Anabilim Dali Mugla 48000, Türkiye
Country
Turkey
Secondary sponsor category [1] 298239 0
Individual
Name [1] 298239 0
Ezgi Dinçer
Address [1] 298239 0
Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon Anabilim Dali Mugla 48000, Türkiye
Country [1] 298239 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299951 0
Mugla Sitki Kocman University Clinical Trials Ethics Committee
Ethics committee address [1] 299951 0
Mugla Sitki Kocman University Clinical Trials Ethical Committee Mugla Sitki Kocman University Mdical faculty Dean office 48000 MUGLA /TURKEY
Ethics committee country [1] 299951 0
Turkey
Date submitted for ethics approval [1] 299951 0
03/02/2016
Approval date [1] 299951 0
10/02/2016
Ethics approval number [1] 299951 0
VII

Summary
Brief summary
Safe and adequate return of airway reflexes and cognitive functions during recovery period after general anaesthesia is important especially in short-term paediatric surgeries. The most stressful experience for children during perioperative period is anaesthesia induction but awakening in foreign environment without parents is similarly stressful. We purposed to search if sugammadex causes or increases emergence agitation and laryngospasm due to fast termination of the neuromuscular blockage and quick awakening.

Ninety ASA 1 children between 3-15 years will be included the study randomized and prospectively and will be premedicated with midazolam0.5 mg/kg orally. Standard monitoring procedures per the American Society of Anaesthesiologists and train of four (TOF)monitoring will be performed. For induction sevoflurane %8 and N2O-O2 %50 or in children which have vascular access propofol 2-3 mg/kg, fentanyl 1 µg/kg, lidocaine 1 mg/kg and rocuronium 0.6 mg/kg will be administered. Anesthesia will be maintained with sevoflurane and N2O-O2. Dexamethasone 0.1 mg/kg, paracetamol 15 mg/kg and ondansetron 0.1 mg/kg will be applied. When the operation finish, inhalation anaesthetics will be stopped and when TOF is %25, neostigmine 50 µg/kg and atropine 0.20 µg/kg(n=45) or sugammadex 2 mg/kg will be applied randomly (double-blinded). Time between TOF %25-90, total anaesthesia, operation and eye-opening times will be recorded. All will be evaluated with agitation scale (AS) and paediatric anaesthesia emergence delirium (PAED) scale in the recovery room. We will call agitated which had AS>3 and PAED>=10.
Trial website
Trial related presentations / publications
.
Public notes
Attachments [1] 2568 2568 0 0
/AnzctrAttachments/374750-Anesthesia protocol.docx (Protocol)

Contacts
Principal investigator
Name 82058 0
Prof Semra Gümüs Demirbilek
Address 82058 0
Mugla Sitki Kocman University , 48000 Kotekli, MUGLA
Country 82058 0
Turkey
Phone 82058 0
+905367648718
Fax 82058 0
+902522111000
Email 82058 0
sedemirbilek@gmail.com
Contact person for public queries
Name 82059 0
Prof Semra Gümüs Demirbilek
Address 82059 0
Mugla Sitki Kocman University , 48000 Kotekli, MUGLA
Country 82059 0
Turkey
Phone 82059 0
+905367648718
Fax 82059 0
+902522111000
Email 82059 0
sedemirbilek@gmail.com
Contact person for scientific queries
Name 82060 0
Prof Semra Gumus Demirbilek
Address 82060 0
Mugla Sitki Kocman University , 48000 Kotekli, MUGLA
Country 82060 0
Turkey
Phone 82060 0
+905367648718
Fax 82060 0
+902522111000
Email 82060 0
sedemirbilek@gmail.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?
all of the individual participant data collected during the trial
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results
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, requirement to sign data access agreement


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.