ANZCTR - Registration

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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

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]

none

Universal Trial Number (UTN)

U1111-1211-0577

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

emergence agitation

Condition category

Condition code

Anaesthesiology

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]

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]

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]

first 15 minutes in the recovery room

Primary outcome [2]

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]

first 15 minutes in the recovery room

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Mugla

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Mugla Sitki Kocman University Training and Research Hospital

Address [1]

Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon Anabilim Dali Mugla 48000, Türkiye

Country [1]

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]

Individual

Name [1]

Ezgi Dinçer

Address [1]

Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon Anabilim Dali Mugla 48000, Türkiye

Country [1]

Turkey

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mugla Sitki Kocman University Clinical Trials Ethics Committee

Ethics committee address [1]

Mugla Sitki Kocman University Clinical Trials Ethical Committee Mugla Sitki Kocman University Mdical faculty Dean office 48000 MUGLA /TURKEY

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

03/02/2016

Approval date [1]

10/02/2016

Ethics approval number [1]

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]

/AnzctrAttachments/374750-Anesthesia protocol.docx (Protocol)

Contacts

Principal investigator

Name

Prof Semra Gümüs Demirbilek

Address

Mugla Sitki Kocman University , 48000 Kotekli, MUGLA

Country

Turkey

Phone

+905367648718

Fax

+902522111000

sedemirbilek@gmail.com

Contact person for public queries

Name

Semra Gümüs Demirbilek

Address

Mugla Sitki Kocman University , 48000 Kotekli, MUGLA

Country

Turkey

Phone

+905367648718

Fax

+902522111000

sedemirbilek@gmail.com

Contact person for scientific queries

Name

Semra Gumus Demirbilek

Address

Mugla Sitki Kocman University , 48000 Kotekli, MUGLA

Country

Turkey

Phone

+905367648718

Fax

+902522111000

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.

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