Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613001252707
Ethics application status
Approved
Date submitted
10/11/2013
Date registered
14/11/2013
Date last updated
14/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Determination Of Optimum Time For Intravenous Cannulation after Induction with Sevoflurane, Nitrous Oxide mixture in children undergoing Midazolam Sedation
Scientific title
Optimum time for intravenous cannulation after inhalational induction of sevoflurane and nitrous oxide general anaesthesia after midazolam premedication in children undergoing elective surgery
Secondary ID [1] 283556 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aim of this study to determine the optimal time of intravenous
cannulation in children induced with sevoflurane. 290462 0
Condition category
Condition code
Anaesthesiology 290854 290854 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Children will premedicated with oral midazolam (0.5 mg/kg) mixed in a small amount of strawberry syrup (total volume of 5 ml).
General anesthesia was induced with sevoflurane and nitrous oxide via face mask .For the first child, four minutes after the loss of eyelash reflex, the intravenous cannulation was attempted by an experienced anesthetist. At the time of intravenous canulation attempt, an independent observer who was blinded about predetermined canulation time, rated the movement according to a scale (0= no movement 1= slight extremity tensing, 2= extremity withdrawal, 3=generalized movement). Intravenous
cannulation without any laryngospasm or movement was considered successful.The intravenous cannulation time of the next patient was determined by the use of up-and-down method (15 s as a step size).The observation was
concluded after intravenous cannulation and the case
proceeded as per routine. The sample size of the patients is based on Dixon’s up-and-down method that requires at least six
pairs of failure success.
Intervention code [1] 288250 0
Not applicable
Comparator / control treatment
N/A - This is an observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290850 0
Determination of optimum time for intravenous cannulation after induction with Sevoflurane, Nitrous Oxide mixture in children undergoing Midazolam Sedation

At the time of intravenous canulation attempt, an independent observer who was blinded about predetermined canülation time, rated the movement according to a scale (0= no movement 1= slight extremity tensing, 2= extremity withdrawal, 3=generalized movement
Intravenous cannulation without any laryngospasm or movement was considered successful.
At the time of intravenous canulation attempt, an independent observer who was blinded about predetermined canülation time, rated the movement according to a scale (0= no movement 1= slight extremity tensing, 2= extremity withdrawal, 3=generalized movement
Intravenous cannulation without any laryngospasm or movement was considered successful.
Timepoint [1] 290850 0
For the first child, four minutes after the loss of eyelash reflex, the intravenous cannulation was attempted by an experienced anesthetist.The intravenous cannulation time of the next patient was determined by the use of up-and-down method (15 s as a step size). Assessed and concluded immediately after iv cannulation.
Secondary outcome [1] 305439 0
To assess Bispectral Index BIS changes during induction of anaesthesia with sevoflurane in children premedicated with midazolam
Timepoint [1] 305439 0
BIS values at preinduction, loss of eyelash reflex, before and after (10 s) cannulation attempt and when the pupils return to the mid position will recorded.

Eligibility
Key inclusion criteria
Participant are children with ASA physical status I and scheduled for an elective procedure under general anesthesia without prior intravenous cannulation were selected.
Minimum age
2 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
history of an upper respiratory tract infection,abnormal airway, reactive airway disease,

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The sample size calculation is on Dixon's method that needs at least six pairs of failure-success .

Probit test will used for analysis of up-and-down sequences to obtain the time for intravenous cannulation and calculating 95% confidence limits (CL) of the mean.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2013
Date of last participant enrolment
Anticipated
14/11/2013
Actual
7/11/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment outside Australia
Country [1] 5577 0
Turkey
State/province [1] 5577 0

Funding & Sponsors
Funding source category [1] 288240 0
University
Name [1] 288240 0
Necmettin Erbakan University

Department of Anesthesiology and Reanimation
Country [1] 288240 0
Turkey
Primary sponsor type
University
Name
Necmettin Erbakan University
Address
Necmettin Erbakan University

Department of Anesthesiology and Reanimation

Meram School of Medicine 42080

Meram, Konya, TURKEY
Country
Turkey
Secondary sponsor category [1] 286958 0
None
Name [1] 286958 0
Address [1] 286958 0
Country [1] 286958 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290145 0
Necmettin Erbakan University Department of Anesthesiology and Reanimation Meram School of Medicine
Ethics committee address [1] 290145 0
Necmettin Erbakan University

Department of Anesthesiology and Reanimation

Meram School of Medicine 42080

Meram, Konya, TURKEY
Ethics committee country [1] 290145 0
Turkey
Date submitted for ethics approval [1] 290145 0
09/04/2012
Approval date [1] 290145 0
17/04/2012
Ethics approval number [1] 290145 0
2012.42

Summary
Brief summary
It has been shown that early placement of an intravenous cannulation in children anesthetized with sevoflurane movement was greater, and the incidence of laryngospasm was higher. The aim of this study is determine the optimal time for safe intravenous cannulation in children induced with sevoflurane and nitrous oxide after midazolam premedication.
Children aged 2-6 years, ASA physical status I, will scheduled for an elective procedure under general anesthesia will recruited. Patients will received oral midazolam(0.5 mg) Inhalational anesthesia will induced with sevoflurane nitrous oxide via mask, then intravenous cannulation will attempted. The time for intravenous cannulation will determined by the use of up-and-down method using 15 s as a step size. Intravenous cannulation without any movement, or laryngospasm will considered successful. The up-and-down sequences will analyzed by the probit test. The sample size calculation will based on Dixon's method that needs at least six pairs of failure-success
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44170 0
A/Prof Alper Kilicaslan
Address 44170 0
Necmettin Erbakan University

Department of Anesthesiology and Reanimation

Meram School of Medicine 42080

Meram, Konya, TURKEY
Country 44170 0
Turkey
Phone 44170 0
+905053780376
Fax 44170 0
Email 44170 0
[email protected]
Contact person for public queries
Name 44171 0
Prof Seref Otelcioglu
Address 44171 0
Necmettin Erbakan University

Department of Anesthesiology and Reanimation

Meram School of Medicine 42080

Meram, Konya, TURKEY
Country 44171 0
Turkey
Phone 44171 0
+903322236550
Fax 44171 0
Email 44171 0
[email protected]
Contact person for scientific queries
Name 44172 0
Prof Seref Otelcioglu
Address 44172 0
Necmettin Erbakan University

Department of Anesthesiology and Reanimation

Meram School of Medicine 42080

Meram, Konya,
Country 44172 0
Turkey
Phone 44172 0
+903322236550
Fax 44172 0
Email 44172 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
No additional documents have been identified.