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Trial registered on ANZCTR


Registration number
ACTRN12613000131752
Ethics application status
Approved
Date submitted
26/01/2013
Date registered
4/02/2013
Date last updated
4/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating clinical features of reversed non depolarizing block by using train- of -four (TOF) responses recorded by acceleromyography device in pediatric patients
Scientific title
Comparison of the effects of sugammadex and anticholinergic-anticholinestarese agents for reversing non depolarizing block in pediatric patients
Secondary ID [1] 281843 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenotonsillitis where surgery is necessary 288202 0
Otitis Media where surgery is necessary 288203 0
Other ilnessess in pediatric patients that can be operated by ear nose and throat surgeons under general anesthesia 288204 0
Condition category
Condition code
Anaesthesiology 288572 288572 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2mg/kg sugammadex intravenously will be given only once when T2 point (two contractions) on TOF device is observed in group I patients.
TOF device is used for evaluating the level of neuromuscular block after neuromuscular blocker medications. Entubation and extubation time of the patient decided correctly and easily by using this device. Different kinds of electrical stimulations are used like;Train-Of-Four Ratio,Single twitch,Double-burst stimulation, Post-tetanic count. We used TOF device during the surgery started after anesthesia induction (before neuromuscular blocker agent was given) to extubation time .
Intervention code [1] 286402 0
Treatment: Drugs
Intervention code [2] 286403 0
Treatment: Other
Comparator / control treatment
0.06mg/kg neostigmin + 0.02 mg/kg atropin intravenously will be given only once when T2 point (two contractions) on TOF device is observed in group 2 patients
Control group
Active

Outcomes
Primary outcome [1] 288726 0
1- T 0.9 reaching time of groups and significant difference between them were tested after reversing agent administration by using TOF accelomyelography device
Timepoint [1] 288726 0
1- At 15., 30., 60., 90. seconds and 2., 5., 10.,15.,20., 25., 30.minutes after reversing of blockade period.
Secondary outcome [1] 300847 0
1- Extubation time: At the moment of T 0.9 on TOF device inhalation gases were ceased and patients were extubated properly after spontaneous breathing.
Timepoint [1] 300847 0
1-At 15., 30., 60., 90. seconds and 2., 5., 10.,15.,20., 25., 30.minutes after reversing of blockade period.
Secondary outcome [2] 300848 0
2- Respiration status was assessed as;able to breath and coughing: 2, dyspnea or limited respiration: 1
Respiration status is one of the criteria of Modified Aldrete scoring system which is is commonly used for determining when a patient can safely be discharged from the postanesthesia care unit The Aldrete scoring system takes into account the patient's ability to move, respiration, circulation, consciousness, and oxygen saturation. A maximum of two points are awarded in each category and a score of 9 or 10 is required for discharge.
Timepoint [2] 300848 0
2- At 5., 10.,15.,20., 25., 30. minutes after extubation
Secondary outcome [3] 300849 0
3- Muscle strength were assessed as;
a)total paralyze: 0, no loss of muscle strength:10
b)head elevation more than 5 seconds yes:1 , no:2
c)exhibiting tongue yes: 1 ,no:2
These are the signs of clinical recovery of neuromuscular function. All of them are subjective, bedside tests used in post anesthesia care unit for determining that a patient can be discharged from the unit.
Timepoint [3] 300849 0
3- At 5., 10.,15.,20., 25., 30. minutes after extubation
Secondary outcome [4] 300850 0
4-Hemodynamic alterations(changes on hearth rate and mean arterial blood pressure)
Timepoint [4] 300850 0
4-At 0., 2., 5., 10., 30. minutes after entubation and (as well as) 15., 30., 60., 90. seconds and 2., 5., 10.,15.,20., 25., 30.minutes after reversing of blockade period

Eligibility
Key inclusion criteria
Pediatric patients age between2-12 and ASA1-2 whom should be performed general anesthesia in supine position for ear nose and throat surgery.
Minimum age
2 Years
Maximum age
12 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were; intubation limitations, drug uptake that can cause interaction with rocuronium, neuromuscular diseases, renal diseases and known malign hyperthermia in the family history.

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)
Randomization was performed using a sealed opaque envelope with a computer- generated block random allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was performed using a sealed opaque envelope with a computer- generated block random allocation.
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 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Shapiro Wilk test was performed in order to reveal constant variants’ distributions. For constant variants descriptive analysis involved mean ± standard deviation or median (minimum-maximum) values and for the categorical variants involved values of number of cases and percentages (%). Significance of differences of mean values tested by Student’s t test while significance of differences of median values tested by Mann Whitney U test. Categorical variants analysed by Pearson’s Chi square or Fischer’s Chi-square test. Repeated measurements, including heart rate, mean arterial pressure, saturation and TOF data were evaluated by variant analysis of repeated measurements. Greenhouse-Geisser method was performed in order to detect differences among groups, in terms of follow-up durations and characteristics. Since P<0.05 was accepted as error value, Bonferroni correction was performed to avoid type 1 mistakes in all multiple comparisons.

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] 4823 0
Turkey
State/province [1] 4823 0
Ankara

Funding & Sponsors
Funding source category [1] 286627 0
Self funded/Unfunded
Name [1] 286627 0
Address [1] 286627 0
Country [1] 286627 0
Turkey
Primary sponsor type
Hospital
Name
Ministry of Health Ankara Training and Research Hospital
Address
Ulucanlar caddesi Sukriye mahallesi No:89 06340 Altindag/Ankara
Country
Turkey
Secondary sponsor category [1] 285412 0
None
Name [1] 285412 0
Address [1] 285412 0
Country [1] 285412 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288705 0
Local Ethics Committee of Ministry of Health Ankara Training and Research Hospital
Ethics committee address [1] 288705 0
Sukriye mahallesi Ulucanlar caddesi No:89 06340 Altindag/Ankara
Ethics committee country [1] 288705 0
Turkey
Date submitted for ethics approval [1] 288705 0
29/07/2011
Approval date [1] 288705 0
10/08/2011
Ethics approval number [1] 288705 0
0428

Summary
Brief summary
Sixty children age between 2-12 in ASA I-II scheduled for elective surgery in supine position were enrolled to this randomized, prospective, double-blinded study after the permission of local ethics committee and parents written informed consent. Patients were randomized to two groups as Group I (sugammadex) and Group II (neostigmine). Propofol (2mg/kg) and fentanyl (1?g/kg) were administered for induction and sevoflurane for maintenance of anaesthesia. Neuromuscular function was monitored by acceleromyography (TOF Watch SX) and train-of-four (TOF) mode of stimulation. Rocuronium (0.6mg/kg) was used for NMB and 0.1-0.2 mg/kg additional doses were given if necessary. At reappearance of T2, sugammadex 2mg/kg in group I and neostigmine 0.06mg/kg+atropine 0.02 mg/kg in group II were administered. Patients were extubated after TOF 0.9 was achieved. No statistically significant difference was observed between the groups according to age, gender, weight, duration of operation, mean arterial pressure, SpO2, fentanyl and rocuronium usages (p>0.05).Heart rate decreased significantly after reversal agent in group I at 15th,30th and 60th seconds of evaluation whereas it increased significantly in group II (p<0.0004).Time from administration of reversal agent to TOF 0.9 was faster with sugammadex (68 second) than with neostigmine (392 second) (p<0.001). Muscle strength was significantly higher in group I than in group II. The result of this study shows sugammadex is a safe and effective agent for reversing rokuronium–induced NMB in paediatric patients with a faster recovery of neuromuscular function than neostigmine.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37358 0
A/Prof Hulya Basar
Address 37358 0
Ministry of Health Ankara Training and Research Hospital Anesthesiology and Reanimation Department Sukriye mahallesi Ulucanlar caddesi No:89 06340 Altindag/Ankara
Country 37358 0
Turkey
Phone 37358 0
+90 312 5953180
Fax 37358 0
Email 37358 0
hulya_basar@yahoo.com
Contact person for public queries
Name 37359 0
A/Prof Hulya Basar
Address 37359 0
Ministry of Health Ankara Training and Research Hospital Anesthesiology and Reanimation Department
Sukriye mahallesi Ulucanlar caddesi No:89 06340 Altindag/Ankara
Country 37359 0
Turkey
Phone 37359 0
+90 312 5953180
Fax 37359 0
Email 37359 0
hulya_basar@yahoo.com
Contact person for scientific queries
Name 37360 0
Dr Turkay Cakan
Address 37360 0
Ministry of Health Ankara Training and Research Hospital Anesthesiology and Reanimation Department
Sukriye mahallesi Ulucanlar caddesi No:89 06340 Altindag/Ankara
Country 37360 0
Turkey
Phone 37360 0
+90 312 5953175
Fax 37360 0
Email 37360 0
turkaycakan@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