Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000657729
Ethics application status
Approved
Date submitted
8/06/2013
Date registered
14/06/2013
Date last updated
11/02/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A study on the optimum bolus dose of alfentanil for laryngeal mask airway insertion when co-administered with a single standard dose of propofol in children
Scientific title
A study on the optimum bolus dose of alfentanil for laryngeal mask airway insertion when co-administered with a single standard dose of propofol in children
Secondary ID [1] 282642 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Induction of general anaesthesia in children 289344 0
Condition category
Condition code
Anaesthesiology 289680 289680 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A predetermined bolus dose of alfentanil was injected over 30 seconds, followed by propofol 2.5 mg/kg over 10 seconds. The bolus dose of alfentanil was determined by a modified Dixon’s up-and-down method, starting from 10 microg/kg (2microg/kg as a step size). Laryngeal mask insertion was attempted 90 seconds after the end of alfentanil injection and the response of patients was classified as either ‘success’ or ‘failure’.
Intervention code [1] 287309 0
Not applicable
Comparator / control treatment
N/A-this is an observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289768 0
To determine the optimum bolus dose of alfentanil for laryngeal mask airway insertion the in children by using Dixon and Massey up and down method
Timepoint [1] 289768 0
At the time of LMA insertion
Secondary outcome [1] 303203 0
The incidence and severity of injection pain of propofolThe incidence and severity of injection pain of propofol were assessed using the fourpoint scale : 0 = no pain; 1 = mild
pain (grimace); 2 = moderate pain (grimace + cry); and
3 = severe pain (cry + withdrawal).
Timepoint [1] 303203 0
during the period of intravenous induction
Secondary outcome [2] 303204 0
Incidence of adverse events as recorded in each patient's diary/health record for the trial (e.g.laryngospasm,gapping,cough,hypotention,bradycardia)
Timepoint [2] 303204 0
during the period of LMA insertion

Eligibility
Key inclusion criteria
ASA 1 and 2 patients of either gender of the age 3- 7 years undergoing elective 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
airway malformations, clinical evidence of patients with difficult airway, asthma or any sign of upper respiratory tract infection.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
up and down method

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/06/2013
Actual
7/08/2014
Date of last participant enrolment
Anticipated
Actual
28/11/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment outside Australia
Country [1] 5135 0
China
State/province [1] 5135 0
Fujian Province

Funding & Sponsors
Funding source category [1] 287422 0
Self funded/Unfunded
Name [1] 287422 0
Yusheng Yao
Country [1] 287422 0
China
Primary sponsor type
Individual
Name
Yusheng Yao
Address
No.134 Dongjie Street,Fujian Provincial Hospital, Fuzhou, Fujian, China, 350001
Country
China
Secondary sponsor category [1] 286170 0
Individual
Name [1] 286170 0
Yangqin Chen
Address [1] 286170 0
No.134 Dongjie Street, Fujian Provincial Hospital, Fuzhou, Fujian, China, 350001
Country [1] 286170 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289403 0
The Ethics and Committee of Fujian Provincial Hospital
Ethics committee address [1] 289403 0
No.134 Dongjie Street, Fuzhou, Fujian, China, 350001
Ethics committee country [1] 289403 0
China
Date submitted for ethics approval [1] 289403 0
10/05/2013
Approval date [1] 289403 0
06/06/2013
Ethics approval number [1] 289403 0
FJSL-2013-06-06

Summary
Brief summary
The use of the laryngeal mask airway in children has increased with increasing day-case surgery in paediatric
patients. Successful insertion of the laryngeal mask
requires adequate mouth opening and sufficient depth
of anaesthesia to minimise the upper airway reflexes and
to prevent the untoward events of coughing, gagging and
laryngospasm. Although propofol is a commonly used induction agent due to its depressant effects on airway reflexes, propofol alone does not prevent undesirable airway responses.Consequently, a potent and short-acting opioid (for example alfentanil ) is often added to facilitate laryngeal mask insertion in adults with minimal haemodynamic changes.However, the optimal bolus dose
of alfentanil for children in this context has not been
established. This study was designed, therefore, to determine the optimal dose of alfentanil required for the
successful insertion of the laryngeal mask airway with a
single bolus dose of propofol at induction (2.5 mg/kg)without a neuromuscular blocking agent in children.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40630 0
Dr Yusheng Yao
Address 40630 0
No.134 Dongjie Street, Fujian Provincial Hospital,Fuzhou, Fujian, China, 350001
Country 40630 0
China
Phone 40630 0
+86 13559939629
Fax 40630 0
Email 40630 0
[email protected]
Contact person for public queries
Name 40631 0
Yusheng Yao
Address 40631 0
No.134 Dongjie Street, Fujian Provincial Hospital,Fuzhou, Fujian, China, 350001
Country 40631 0
China
Phone 40631 0
+86 13559939629
Fax 40631 0
Email 40631 0
[email protected]
Contact person for scientific queries
Name 40632 0
Yusheng Yao
Address 40632 0
No.134 Dongjie Street, Fujian Provincial Hospital,Fuzhou, Fujian, China, 350001
Country 40632 0
China
Phone 40632 0
+86 13559939629
Fax 40632 0
Email 40632 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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Documents added automatically
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