Intravenous CannulationNCT03851692
Intravenous Cannulation In Children During Sevoflurane Induction
A study testing Intravenous Cannulation (iv placement) in people with Intravenous Cannulation and Sevoflurane Induction, run by University Hospital Fattouma Bourguiba.
Trial summary
The early placement of an intravenous (iv) line in children anesthetized with halothane has been shown safe and acceptable compared with later placement. However, there's not well known with sevoflurane use (2). Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Intravenous Cannulation, Sevoflurane Induction, Child
- What is being tested?
- Intravenous Cannulation (iv placement)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 31 Dec 2016
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I, II
- Age from 1 to 12 years old
- Ambulatory surgery under general anesthesia.
Who cannot join
- Age <1 year or> 12 years
- non-ambulatory surgery,
- contraindication for induction with sevoflurane
About this study
Official title: Intravenous Cannulation In Children During Sevoflurane Induction: Which Time is Adequate
The early placement of an intravenous (iv) line in children anesthetized with halothane has been shown safe and acceptable compared with later placement. However, there's not well known with sevoflurane use (2). The aim of the investigator's study is to determine whether one should make iv attempts during the early induction period (at 60seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia
Read the detailed description
the investigators conducted a prospective randomized study, after obtaining Institutional review board approval, which didn't require written parental consent. Children age 1-12 years, undergoing elective general anesthesia via an inhalation induction were randomized to one of three groups of 30 patients each one, for iv placement, either 60s (group E), 90 or 120 s (group L) following loss of lid reflex. Movement on iv placement and incidence of laryngospasm were determined. Difficulty with iv placement was also recorded. Statistical analysis included contingency testing, ANOVA, and non parametric testing. A P-value <0.05 was considered significant.
- Conditions
- Intravenous Cannulation, Sevoflurane Induction, Child
- Being tested
- Intravenous Cannulation (iv placement)
- Keywords
- Sevoflurane, Intravenous Cannulation, anesthesia, child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Cannulation (iv placement)Other
The aim of our study is to determine whether one should make intravenous attempts placement during the early induction period (at 60seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 60s (group E) | Active comparator | Intravenous cannulation was released either 60 s following loss of lid reflex in group E Receives: Other: Intravenous Cannulation (iv placement) |
| 90 or 120 s (groupe L) | Active comparator | Intravenous cannulation was released either 90 or 120 s following loss of lid reflex in group L Receives: Other: Intravenous Cannulation (iv placement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement on iv placement
Number of children who presented movement on iv placement
Measured: In the first 5 min after the anesthesic induction with sevoflurane
laryngospasm
The incidence of laryngospasm
Measured: Time From Intravenous Cannulation to patient extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start1 Aug 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intravenous CannulationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized single blinded parallel group controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Fattouma Bourguiba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben ALI Manel, University Hospital Fattouma Bourguiba
- Investigators
- Manel Ben Ali, MD, Principal investigator, University Hospital of Fattouma Bourguiba Monastir TUNISIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851692
- Sponsor's protocol ID
- 0925-0586
- Status last verified
- Feb 2019
- First submitted
- 27 Oct 2018
- Last updated
- 22 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hasan AK, Sivasankar R, Nair SG, Hasan WU, Latif Z. Optimum time for intravenous cannulation after induction with sevoflurane, oxygen, and nitrous oxide in children without any premedication. Paediatr Anaesth. 2018 Feb;28(2):179-183. doi: 10.1111/pan.13308. Epub 2018 Jan 8.
PubMed 29316032Kumar 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 29109638
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Cannulation In Children During Sevoflurane Induction: Which Time is Adequate
- ClinicalTrials.gov ID
- NCT03851692
- Acronym / sponsor ID
- 0925-0586
- Conditions
- Intravenous Cannulation, Sevoflurane Induction, Child
- Keywords
- Sevoflurane, Intravenous Cannulation, anesthesia, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital Fattouma BourguibaUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 22 Feb 2019 (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.
The early placement of an intravenous (iv) line in children anesthetized with halothane has been shown safe and acceptable compared with later placement. However, there's not well known with sevoflurane use (2). The aim of the investigator's study is to determine whether one should make iv attempts during the early induction period (at 60seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia
Detailed description
the investigators conducted a prospective randomized study, after obtaining Institutional review board approval, which didn't require written parental consent. Children age 1-12 years, undergoing elective general anesthesia via an inhalation induction were randomized to one of three groups of 30 patients each one, for iv placement, either 60s (group E), 90 or 120 s (group L) following loss of lid reflex. Movement on iv placement and incidence of laryngospasm were determined. Difficulty with iv placement was also recorded. Statistical analysis included contingency testing, ANOVA, and non parametric testing. A P-value <0.05 was considered significant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized single blinded parallel group controlled study
| Arm | Type | Receives |
|---|---|---|
| 60s (group E) | Active comparator | Other: Intravenous Cannulation (iv placement)Intravenous cannulation was released either 60 s following loss of lid reflex in group E |
| 90 or 120 s (groupe L) | Active comparator | Other: Intravenous Cannulation (iv placement)Intravenous cannulation was released either 90 or 120 s following loss of lid reflex in group L |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I, II
- Age from 1 to 12 years old
- Ambulatory surgery under general anesthesia.
Key exclusion criteria (3 listed)
- Age <1 year or> 12 years
- non-ambulatory surgery,
- contraindication for induction with sevoflurane
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 |
|---|---|---|
| Intravenous Cannulation (iv placement)The aim of our study is to determine whether one should make intravenous attempts placement during the early induction period (at 60seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia. | Other | 60s (group E), 90 or 120 s (groupe L) |
Primary outcome
Movement on iv placement
Time frame: In the first 5 min after the anesthesic induction with sevoflurane
Number of children who presented movement on iv placement
laryngospasm
Time frame: Time From Intravenous Cannulation to patient extubation
The incidence of laryngospasm
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 22 Feb 2019.
- Background: PubMed 29316032Hasan AK, Sivasankar R, Nair SG, Hasan WU, Latif Z. Optimum time for intravenous cannulation after induction with sevoflurane, oxygen, and nitrous oxide in children without any premedication. Paediatr Anaesth. 2018 Feb;28(2):179-183. doi: 10.1111/pan.13308. Epub 2018 Jan 8.
- Background: 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.
- Individual participant dataSharing planned: No
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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.
Manel Ben Ali, MD principal investigator
University Hospital of Fattouma Bourguiba Monastir TUNISIA
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous Cannulation (iv placement) in people with Intravenous Cannulation and Sevoflurane Induction, run by University Hospital Fattouma Bourguiba.
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 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Movement on iv placement (time frame: In the first 5 min after the anesthesic induction with sevoflurane). The study lists 2 primary outcomes in all. 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 NCT03851692, which also lists 2 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 22 Feb 2019.