Movement After Intravenous CannulationNCT04284579
Optimum Time for Intravenous Cannulation After Induction With Sevoflurane in Pediatric Patient
A study testing IV cannula in people with Movement After Intravenous Cannulation, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study aimed to determinate effective dose 95 (ED95) intravenous cannulation in pediatric patient after induction of sevoflurane 8 vol% Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Movement After Intravenous Cannulation
- What is being tested?
- IV cannula
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteIndonesia
- Study dates
- 27 May 2019to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 1-3 year
- Physical state ASA I dan II
- Parents of patients who agreed to participate and sign informed consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
This study aimed to determinate effective dose 95 (ED95) intravenous cannulation in pediatric patient after induction of sevoflurane 8 vol%
Read the 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.
- Conditions
- Movement After Intravenous Cannulation
- Being tested
- IV cannula
- Keywords
- child, general anesthesia, induction of anesthesia, sevoflurane, venous cannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV cannulaDevice
We measure the time duration needed for IV cannulation
| Study group | Role | What they receive |
|---|---|---|
| time for cannulation | Experimental | intravenous cannulation after sevoflurane induction Receives: Device: IV cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED50 in intravenous cannulation after sevoflurane induction
using Dixon Up and Down Method
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start27 May 2019
- Primary completion5 Jul 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Movement After Intravenous CannulationStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jefferson K Hidayat, Universitas Indonesia
- Investigators
- Jefferson K Hidayat, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284579
- Sponsor's protocol ID
- IndonesiaUAnes50
- Status last verified
- Feb 2020
- First submitted
- 23 Feb 2020
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15385009Kumar 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.
PubMed 29109638Kilicaslan 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.
PubMed 25623378Whalen 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.
PubMed 16013684Behne M, Wilke HJ, Harder S. Clinical pharmacokinetics of sevoflurane. Clin Pharmacokinet. 1999 Jan;36(1):13-26. doi: 10.2165/00003088-199936010-00002.
PubMed 9989340
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04284579
- Acronym / sponsor ID
- IndonesiaUAnes50
- Conditions
- Movement After Intravenous Cannulation
- Keywords
- child, general anesthesia, induction of anesthesia, sevoflurane, venous cannulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 27 May 2019 (actual)
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| time for cannulation | Experimental | Device: IV cannulaintravenous cannulation after sevoflurane induction |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 1-3 year
- Physical state ASA I dan II
- Parents of patients who agreed to participate and sign informed consent.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV cannulaWe measure the time duration needed for IV cannulation | Device | time for cannulation |
Primary outcome
ED50 in intravenous cannulation after sevoflurane induction
Time frame: 2 minutes
using Dixon Up and Down Method
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Results publication: PubMed 15385009Schwartz 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.
- Results publication: PubMed 29109638Kumar 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.
- Results publication: PubMed 25623378Kilicaslan 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.
- Results publication: PubMed 16013684Whalen 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.
- Results publication: PubMed 9989340Behne M, Wilke HJ, Harder S. Clinical pharmacokinetics of sevoflurane. Clin Pharmacokinet. 1999 Jan;36(1):13-26. doi: 10.2165/00003088-199936010-00002.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jefferson K Hidayat principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV cannula in people with Movement After Intravenous Cannulation, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED50 in intravenous cannulation after sevoflurane induction (time frame: 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04284579, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.