Clinical trial NCT04284579: Optimum Time for Intravenous Cannulation After Induction With Sevoflurane in Pediatric Patient
Official title: Determination Effective Dose 95 (ED95) of Intravenous Cannulation With the Induction of Sevoflurane 8 Vol% in Patients Aged 1-3 Years Using Dixon up and Down Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Movement After Intravenous Cannulation
Keywords: child, general anesthesia, induction of anesthesia, sevoflurane, venous cannulation
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 22
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study aimed to determinate effective dose 95 (ED95) intravenous cannulation in pediatric patient after induction of sevoflurane 8 vol%

Detailed description: Twenty-two subjects were given informed consent before study enrolled. Anesthesia was induced by 8% sevoflurane with 6 L flow of 100% oxygen. IV cannulation was attempted at 2 min in the first child in each group. The time for cannulation in the next child was stepped up or down by 15 s depending on positive or negative response, respectively, in the previous child. Children were recruited till a minimum of six pairs of failure-success sequence which was obtained in the group. The mean of midpoints of the failure-success sequence was calculated to obtain the time for cannulation in 50% of the group.

Eligibility criteria: Inclusion Criteria:

* Age 1-3 year
* Physical state ASA I dan II
* Parents of patients who agreed to participate and sign informed consent.

Exclusion criteria:

* Patients with difficult airway
* There's allergic reaction or drug's side effect after induction
* There's cardiorespiratory problem such as anaphylactic shock, aritmia, severe hypotension, desaturation before-on-or after induction

Primary outcomes:
measure: ED50 in intravenous cannulation after sevoflurane induction
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Indonesia University
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Jefferson K Hidayat
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwartz D, Connelly NR, Gutta S, Freeman K, Gibson C. Early intravenous cannulation in children during sevoflurane induction. Paediatr Anaesth. 2004 Oct;14(10):820-4. doi: 10.1111/j.1460-9592.2004.01315.x.
citation: Kumar KR, Sinha R, Chandiran R, Pandey RK, Darlong V, Chandralekha. Evaluation of optimum time for intravenous cannulation after sevoflurane induction of anesthesia in different pediatric age groups. J Anaesthesiol Clin Pharmacol. 2017 Jul-Sep;33(3):371-374. doi: 10.4103/joacp.JOACP_58_16.
citation: Kilicaslan A, Gok F, Erol A, Okesli S, Sarkilar G, Otelcioglu S. Response to Makkar and Singh's comment on our article 'Determination of optimum time for intravenous cannulation after induction with sevoflurane and nitrous oxide in children premedicated with midazolam'. Paediatr Anaesth. 2015 Mar;25(3):328-9. doi: 10.1111/pan.12611. No abstract available.
citation: Whalen FX, Bacon DR, Smith HM. Inhaled anesthetics: an historical overview. Best Pract Res Clin Anaesthesiol. 2005 Sep;19(3):323-30. doi: 10.1016/j.bpa.2005.02.001.
citation: Behne M, Wilke HJ, Harder S. Clinical pharmacokinetics of sevoflurane. Clin Pharmacokinet. 1999 Jan;36(1):13-26. doi: 10.2165/00003088-199936010-00002.