Optimum Time for Intravenous Cannulation After Induction With Sevoflurane in Pediatric Patient

Movement After Intravenous Cannulation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04284579
• Other study ID #: IndonesiaUAnes50
• Status: Completed
• Phase: N/A
• Start date: May 27, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: February 2020
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 30, 2019
• Est. primary completion date: July 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Movement After Intravenous Cannulation

Intervention

Device:
• IV cannula
We measure the time duration needed for IV cannulation

Locations

Country	Name	City	State
Indonesia	Indonesia University	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (5)

Behne M, Wilke HJ, Harder S. Clinical pharmacokinetics of sevoflurane. Clin Pharmacokinet. 1999 Jan;36(1):13-26. Review. — View Citation

Kilicaslan A, Gök 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 w — View 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):371-3 — View 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. — View Citation

Whalen FX, Bacon DR, Smith HM. Inhaled anesthetics: an historical overview. Best Pract Res Clin Anaesthesiol. 2005 Sep;19(3):323-30. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ED50 in intravenous cannulation after sevoflurane induction	using Dixon Up and Down Method	2 minutes