Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000462785
Ethics application status
Approved
Date submitted
4/04/2013
Date registered
23/04/2013
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Date results information initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Intranasal Dexmedetomidine Premedication on the Minimum Alveolar Concentration of Sevoflurane for the Insertion of Laryngeal Mask Airway in children
Scientific title
The Effect of Intranasal Dexmedetomidine Premedication on Reducing the Minimum Alveolar Concentration of Sevoflurane for the Insertion of Laryngeal Mask Airway in Children
Secondary ID [1] 282252 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Induction and maintenance of general anaesthesia in children 288775 0
Condition category
Condition code
Anaesthesiology 289127 289127 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
GroupD1 received 1mcg/Kg intranasal dexmedetomidine premedication 45min before general anaesthesia; GroupD2 received 2mcg/Kg intranasal dexmedetomidine premedication 45min before general anaesthesia;the intervention and the participants will be monitored throughout the duration of the procedure with follow up ending 4 hours after the procedure has been completed
Intervention code [1] 286868 0
Treatment: Drugs
Comparator / control treatment
Group P received intranasal saline premedication 45min before general anaesthesia;the intervention and the participants will be monitored throughout the duration of the procedure with follow up ending 4 hours after the procedure has been completed
Control group
Placebo

Outcomes
Primary outcome [1] 289245 0
To determine and compare the Minimum Alveolar Concentration of sevoflurane for LMA insertion in children by using Dixon and Massey up and down method
Timepoint [1] 289245 0
At or one minute after LMA insertion
Secondary outcome [1] 302094 0
the incident of adverse events were recorded in each patient's diary/health record for the trial e.g.laryngospasm,gapping,cough
Timepoint [1] 302094 0
Timepoint: during the period of Inhalation induction
Secondary outcome [2] 302183 0
the incidence of emergence agitation was evauated by the Pediatric Anesthesia Emergence Delirium Scale (PAED)
Timepoint [2] 302183 0
Participants will be followed for duration of PACU stay,an expected average of 2h
Secondary outcome [3] 302186 0
Ramsay Sedation Score
Timepoint [3] 302186 0
after intranasal administration every 10min until 60min
Secondary outcome [4] 302187 0
Parent Satisfaction was evauated by the VAS Scale(0-10)
Timepoint [4] 302187 0
at the time of children discharge from PACU

Eligibility
Key inclusion criteria
ASA 1 and 2 patients of either gender of the age 3- 7 years undergoing elective strabismus surgery under general anaesthesia which can be performed with LMA insertion
Minimum age
3 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: airway malformations, clinical evidence of patients with difficult airway, asthma or any sign of upper 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)
Children were randomly allocated to one of the three groups to receive premedication either placbo (Group S), dexmedetomidine 1microg/kg (Group D1), or dexmedetomidine 2microg/kg (Group D2) in a double-blinded fashion according to random list generated by a computer. Allocation was concealed by the method of 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 administering 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
the sample size of 28 patients of every patients was base on an alfa=0.05,Beta=0.8

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/04/2013
Actual
13/05/2013
Date of last participant enrolment
Anticipated
Actual
28/11/2013
Date of last data collection
Anticipated
Actual
28/11/2013
Sample size
Target
90
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 4975 0
China
State/province [1] 4975 0
Fujian Province

Funding & Sponsors
Funding source category [1] 287016 0
Self funded/Unfunded
Name [1] 287016 0
Yusheng Yao
Country [1] 287016 0
China
Primary sponsor type
Individual
Name
Yusheng Yao
Address
No.134 Dongjie Street, Fuzhou, Fujian, China, 350001
Country
China
Secondary sponsor category [1] 285799 0
Individual
Name [1] 285799 0
Pro. Yangqin Chen
Address [1] 285799 0
No.134 Dongjie Street, Fuzhou, Fujian, China, 350001
Country [1] 285799 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289056 0
The Ethics and Committee of Fujian Provincal Hospital
Ethics committee address [1] 289056 0
No.134 Dongjie Street, Fuzhou, Fujian, China, 350001
Ethics committee country [1] 289056 0
China
Date submitted for ethics approval [1] 289056 0
10/01/2013
Approval date [1] 289056 0
26/03/2013
Ethics approval number [1] 289056 0

Summary
Brief summary
Sevoflurane is widely employed for inhalational induction of general anaesthesia in children. There is increasing evidence that dexmedetomidine is an effective and safe sedative in children. Laryngeal mask airway is an useful device for pediatric anesthesia. The aim of the current study was to determine whether Intranasal dexmedetomidine premedication can reduce MAC of sevoflurane for an LMA insertion in children
Trial website
Trial related presentations / publications
Intranasal dexmedetomidine premedication reduces minimum alveolar concentration of sevoflurane for laryngeal mask airway insertion and emergence delirium in children: a prospective, randomized, double-blind, placebo-controlled trial.
Yao Y, Qian B, Lin Y, Wu W, Ye H, Chen Y.
Paediatr Anaesth. 2015 May;25(5):492-8. doi: 10.1111/pan.12574. Epub 2014 Dec 8.
PMID: 25487567
Public notes

Contacts
Principal investigator
Name 39014 0
Dr Yusheng Yao
Address 39014 0
No.134 Dongjie Street, Fuzhou, Fujian, China, 350001
Country 39014 0
China
Phone 39014 0
86-13559939629
Fax 39014 0
Email 39014 0
[email protected]
Contact person for public queries
Name 39015 0
Prof Yanqing Chen
Address 39015 0
No.134 Dongjie Street, Fuzhou, Fujian, China, 350001
Country 39015 0
China
Phone 39015 0
86-591-87945073
Fax 39015 0
Email 39015 0
[email protected]
Contact person for scientific queries
Name 39016 0
Dr Yusheng Yao
Address 39016 0
No.134 Dongjie Street, Fuzhou, Fujian, China, 350001
Country 39016 0
China
Phone 39016 0
86-13559939629
Fax 39016 0
Email 39016 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only will be shared.
When will data be available (start and end dates)?
The data will be available immediately following publication and no end date.
Available to whom?
Only researchers who provide a methodlgically sound prposal will be able to access this data.
Available for what types of analyses?
These data only to achieve the aims in the approved proposal.
How or where can data be obtained?
The data will be shared access via subject to approvals by Principal Investigator.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Paediatr Anaesth. 2015 May;25(5):492-8. doi: 10.11... [More Details] 363989-(Uploaded-14-11-2018-18-08-31)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIntranasal dexmedetomidine premedication reduces minimum alveolar concentration of sevoflurane for laryngeal mask airway insertion and emergence delirium in children: A prospective, randomized, double-blind, placebo-controlled trial.2015https://dx.doi.org/10.1111/pan.12574
N.B. These documents automatically identified may not have been verified by the study sponsor.