Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000548538
Ethics application status
Approved
Date submitted
19/04/2015
Date registered
28/05/2015
Date last updated
27/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Study on timing of intravenous cannulation before surgery in children
Scientific title
An optimum time for intravenous cannulation after general anaesthesia induction with Sevoflurane and Nitrous Oxide in children undergoing elective surgery without premedication.
Secondary ID [1] 286554 0
Nil
Universal Trial Number (UTN)
U1111-1169-4372
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intravenous cannulation time 294801 0
Condition category
Condition code
Anaesthesiology 295078 295078 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The same anaesthesia machine (Drager Fabius GS, Luback, Germany) will be used in all children with the same circuit volume. The circuit will be emptied and then filled with sevoflurane (8%) and nitrous-oxygen (50:50) for 30 seconds at a high fresh gas flow (6 litre/minute). The timer will be started when the face mask is placed on the child’s face for inhalational induction.

The exhaled gas concentrations will be measured continuously. After the loss of eyelash reflex, fresh gas flow will be reduced to 3 litre/minute, the sevoflurane will be reduced to 5% and the timer will be restarted. Spontaneous respiration will be allowed until intravenous cannulation and ventilation will be gently assisted as required.

For the first child, the gas flow settings will be maintained for 4 minutes from the loss of eyelash reflex before intravenous cannulation is attempted. All intravenous cannulation will be performed on the dorsum of the hand by an experienced anaesthesiologist, using a 22-gauge stainless steel guide cannula (length 19 mm).

At the time of intravenous cannulation attempt, an independent observer, who will be blinded about the predetermined cannulation time, will rate the movement according to a scale (0= no movement, 1= slight extremity tension, 2= extremity withdrawal, 3= generalized movement).
The intravenous cannulation will be considered unsuccessful if there is any movement, cough, or laryngospasm (defined as sudden, partial, or complete loss of air exchange with simultaneous loss of capnographic wave, which require positive pressure ventilation), and the procedure will be considered successful in the absence of any reaction.

The time for the subsequent child’s intravenous cannulation will be adjusted accordingly using Dixon’s up-down sequential method (starting at 4 minutes with 15 second as the step size). The time for cannulation will be increased by 15 seconds if the time is inadequate in the previous child, and conversely, the time for cannulation will be decreased by 15 seconds if the time is adequate in the previous child.

During normal inhalational induction of general anaesthesia the following parameters will be observed-
1. Facemask acceptance grade during induction of general anaesthesia.
2. Time required for the loss of eyelash reflex from the start of general anaesthesia.
3. Exhaled sevoflurane concentration at the time of intravenous cannulation.
4. Patient movement at the time of intravenous cannulation.
5. Presence of cought at the time of intravenous cannulation.
6. Presence of laryngospasm at the time of intravenous cannulation.

Duration:
From the start of induction of general anaesthesia to the time of intravenous cannulation.

Frequency: All these observation will be made only once for each patient.
Intervention code [1] 291769 0
Other interventions
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294842 0
To determine the optimum time for intravenous canulation after the induction of general anaesthesia with sevoflurane, oxygen and nitrous oxide in children without any premedication.

The criteria for optimum time for intravenous cannulation will be no movement at the time of intravenous cannulation. This iwill be observed by an independent observer and graded according to a 4 point scale. This scale was used in study by Kilicaslan A et al. published in Pediatric Anesthesia 2014; 24: 620-624. This scale was not specifically designed for this study.

Timepoint [1] 294842 0
The outcome will be assessed at the time of intravenous cannulation attempt.
Secondary outcome [1] 314183 0
Nil
Timepoint [1] 314183 0
Nil

Eligibility
Key inclusion criteria
American Society of Anesthesiologits (ASA) class l unpremedicated patients for elective procedure undergoing inhalational general anaesthesia induction without intravenous access.
Minimum age
2 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children posted for any emergency procedure, ASA class II and above, Children with abnormal airway anatomy, Children with active respiratory infection in the last 3 weeks, Children with a past history of chronic respiratory disorder, Children who are being treated with sedative or anticonvulsive agents.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The sample size calculation is based on Dixon’s up-down method, which requires at least six pairs of failure-success. Hence, the sample size can not be predetermined prior to start of the study due to the criteria of 6 pairs of success and failure. The time for the subsequent child’s intravenous cannulation will be adjusted accordingly using Dixon’s up-down sequential method (starting at 4 minutes with 15 second as the step size). The time for cannulation will be increased by 15 seconds if the time is inadequate in the previous child, and conversely, the time for cannulation will be decreased by 15 seconds if the time is adequate in the previous child.

The data will be evaluated using the SPSS (statistical Package for the Social Sciences Inc., Chicago, IL, USA) statistical program.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/06/2015
Actual
27/06/2015
Date of last participant enrolment
Anticipated
28/02/2016
Actual
16/04/2016
Date of last data collection
Anticipated
Actual
16/04/2016
Sample size
Target
40
Accrual to date
Final
36
Recruitment outside Australia
Country [1] 6827 0
Brunei Darussalam
State/province [1] 6827 0
Bandar Seri Begawan

Funding & Sponsors
Funding source category [1] 291119 0
Self funded/Unfunded
Name [1] 291119 0
Nil
Country [1] 291119 0
Primary sponsor type
Hospital
Name
Raja Isteri Pengiran Anak Saleha (RIPAS) Hospital
Address
Department of Anaesthesiology, Raja Isteri Pengiran Anak Saleha (RIPAS) Hospital, Jalan Putera Al-Muhtadee Billah, Bandar Seri Begawan, Brunei-Muara, BA1710, Brunei Darussalam.
Country
Brunei Darussalam
Secondary sponsor category [1] 289794 0
None
Name [1] 289794 0
Nil
Address [1] 289794 0
Nil
Country [1] 289794 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292699 0
Medical and Health Research & Ethics committee
Ethics committee address [1] 292699 0
Ethics committee country [1] 292699 0
Brunei Darussalam
Date submitted for ethics approval [1] 292699 0
12/01/2015
Approval date [1] 292699 0
24/03/2015
Ethics approval number [1] 292699 0
MHREC/MOH/2015/2(2)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56622 0
Dr ABM Kamrul Hasan
Address 56622 0
Department of Anaesthesiology, Raja Isteri Pengiran Anak Saleha (RIPAS) Hospital, Jalan Putera Al-Muhtadee Billah, Bandar Seri Begawan, Brunei-Muara, BA1710, Brunei Darussalam.
Country 56622 0
Brunei Darussalam
Phone 56622 0
+6738684579
Fax 56622 0
Email 56622 0
[email protected]
Contact person for public queries
Name 56623 0
ABM Kamrul Hasan
Address 56623 0
Department of Anaesthesiology, Raja Isteri Pengiran Anak Saleha (RIPAS) Hospital, Jalan Putera Al-Muhtadee Billah, Bandar Seri Begawan, Brunei-Muara, BA1710, Brunei Darussalam.
Country 56623 0
Brunei Darussalam
Phone 56623 0
+6738684579
Fax 56623 0
Email 56623 0
[email protected]
Contact person for scientific queries
Name 56624 0
Raman Sivasankar
Address 56624 0
Department of Anaesthesiology, Raja Isteri Pengiran Anak Saleha (RIPAS) Hospital, Jalan Putera Al-Muhtadee Billah, Bandar Seri Begawan, Brunei-Muara, BA1710, Brunei Darussalam.
Country 56624 0
Brunei Darussalam
Phone 56624 0
+6738657294
Fax 56624 0
Email 56624 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOptimum time for intravenous cannulation after induction with sevoflurane, oxygen, and nitrous oxide in children without any premedication.2018https://dx.doi.org/10.1111/pan.13308
N.B. These documents automatically identified may not have been verified by the study sponsor.