ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

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]

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

Condition category

Condition code

Anaesthesiology

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]

Other interventions

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

The outcome will be assessed at the time of intravenous cannulation attempt.

Secondary outcome [1]

Nil

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Brunei Darussalam

State/province [1]

Bandar Seri Begawan

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Nil

Address [1]

Nil

Country [1]

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]

None

Name [1]

Nil

Address [1]

Nil

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Medical and Health Research & Ethics committee

Ethics committee address [1]

Executive Screening Suite, Basement Carpark Level 1, Raja Isteri Pengiran Anak Saleha (RIPAS) Hospital, Bandar Seri Begawan, Brunei-Muara, BA 1710, Brunei Darussalam.

Ethics committee country [1]

Brunei Darussalam

Date submitted for ethics approval [1]

12/01/2015

Approval date [1]

24/03/2015

Ethics approval number [1]

MHREC/MOH/2015/2(2)

Summary

Brief summary

Inhalational mask induction of general anaesthesia with sevoflurane, oxygen and nitrous oxide is a widely practiced technique in children to avoid pain, discomfort and fear of the needle for intravenous cannulation.  Early cannulation during inhalational induction of general anaesthesia may result in movement, precipitation of cough, breath holding and even laryngospasm. Undue delay in cannulation may hinder the safe management of bradycardia, hypotension and apnea. There is limited evidence on the optimal timing for venous cannulation. 

Schwartz et al. concluded that early placement of intravenous cannulation is associated with more movement and respiratory complications. They compared venous cannulation at 30 seconds vs 120 seconds after loss of eyelid reflex during induction of general anaesthesia with sevoflurane and oxygen. Joshi et al. recommended an optimal time of 3.5 minutes for attempting intravenous cannulation after the loss of eyelash reflex with general anaesthesia induction with sevoflurane and oxygen. A recent study by Kilicaslan et al. suggested to wait for 2 minutes before attempting intravenous cannulation following the loss of eyelash reflex in children sedated with midazolam and receiving an inhalation induction of general anaesthesia with sevoflurane and nitrous oxide. 

The current practice in our institution is inhalational mask induction of general anaesthesia with oxygen, nitrous oxide and sevoflurane without premedication for children undergoing elective surgery. However, it is not known if the addition of premedication affects the time for intravenous cannulation following general anaesthesia induction with sevoflurane, oxygen and nitrous oxide. 
We propose to conduct a study to determine the optimum time for intravenous cannulation in children induced with sevoflurane, oxygen and nitrous oxide during general anaesthesia without any premedication.

Trial website

Trial related presentations / publications

A. Hasan, R Sivasankar, S. Nair, Z. Latif. (2016, September 27). Optimum Time for Intravenous Cannulation after Induction with Sevoflurane, Oxygen and Nitrous Oxide in Children without any Premedication. Poster session presented at the 16th World Congress on Pain in Yokohama, Japan.

Public notes

Contacts

Principal investigator

Name

Dr ABM Kamrul Hasan

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

Phone

+6738684579

Fax

drkamrul@gmail.com

Contact person for public queries

Name

ABM Kamrul Hasan

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

Phone

+6738684579

Fax

drkamrul@gmail.com

Contact person for scientific queries

Name

Raman Sivasankar

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

Phone

+6738657294

Fax

sivasankar.raman@gmail.com

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

Source	Title	Year of Publication	DOI
Embase	Optimum time for intravenous cannulation after induction with sevoflurane, oxygen, and nitrous oxide in children without any premedication.	2018	https://dx.doi.org/10.1111/pan.13308

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically