CannulationNCT05139212
Determination of Optimum Time for Intravenous Cannulation in Children With Dexmedetomidine Premedication
An observational study of Cannulation and Sevoflurane Induction, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Inhalational induction with sevoflurane, nitrous oxide, and oxygen is accepted as a safe technique to avoid any movement during intravenous cannulation in children. In addition, intranasal dexmedetomidine could be used for premedication to reduce preoperative anxiety in preschool children. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannulation, Sevoflurane Induction, Dexmedetomidine
- What is being tested?
- Optimum time for intravenous cannulation in children premedicated with dexmedetomidine
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2021to 4 Feb 2022
- Phase
- Observational
- 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 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 2-6 years, American Society of Anesthesiologists physical status 1 scheduled for elective procedures undergoing inhalational induction after dexmedetomidine premedication without intravenous access will be enrolled in the study.
Who may be able to join
- Children with ASA physical status I and scheduled for an elective procedure under general anesthesia without prior intravenous cannulation will be selected
Who cannot join
- 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 who are being treated with sedative or anticonvulsive agents.
- Children with heart, lung, neurologic, or central nervous system disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Optimum Time for Intravenous Cannulation After General Anesthesia Induction With Sevoflurane and Nitrous Oxide in Children Undergoing Elective Surgery With Dexmedetomidine Premedication
Inhalational induction with sevoflurane, nitrous oxide, and oxygen is accepted as a safe technique to avoid any movement during intravenous cannulation in children. In addition, intranasal dexmedetomidine could be used for premedication to reduce preoperative anxiety in preschool children. Early attempts to place, an intravenous line may result in movement and respiratory complications like coughing or laryngospasm. On the other hand delay in cannulation may prevent effective management of bradycardia and hypotension. There are a number of studies examining the optimum time for cannulation after sevoflurane induction. However, it is not known whether the addition of dexmedetomidine premedication affects the time for intravenous cannulation following induction with sevoflurane and nitrous oxide.
Read the detailed description
All the children will be premedicated with intranasal 2mcg/kg dexmedetomidine 40 minutes before the surgery. Ramsay sedation scale and Turkish version of modified Yale Preoperative Anxiety Scale (mYPAS) will be measured at the time of arrival in the daycare unit and during anesthesia preparation in the operating room.
The same anesthesia machine 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 liter/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, the fresh gas flow will be reduced to 3 liter/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 24-gauge stainless steel guide cannula.
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, and the procedure will be considered successful in the absence of any reaction.
The time for the subsequent patient's intravenous cannulation will be adjusted accordingly using Dixon's up-down sequential method (starting at 4 min with 15 s as the step size). The time for cannulation will be increased by 15 s if the time will be inadequate in the previous patient, and conversely, the time for cannulation will be decreased by 15 s if the time will be adequate in the previous patient.
The aim of this study will be to determine the optimum time for intravenous cannulation after the induction of anesthesia with sevoflurane, oxygen, and nitrous oxide in children with intranasal dexmedetomidine premedication.
- Conditions
- Cannulation, Sevoflurane Induction, Dexmedetomidine
- Being tested
- Optimum time for intravenous cannulation in children premedicated with dexmedetomidine
- Keywords
- Induction of anesthesia, Sevoflurane, Nitrous oxide, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimum time for intravenous cannulation in children premedicated with dexmedetomidineProcedure or surgery
The optimum time for intravenous cannulation after the induction of anesthesia with sevoflurane, oxygen, and nitrous oxide in children with intranasal dexmedetomidine premedication will be searched in children undergoing elective surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of optimum time for intravenous cannulation after induction with sevoflurane and nitrous oxide in children premedicated with dexmedetomidine
At the time of intravenous canulation attempt, an independent observer who will be blinded about predetermined canülation time, rated the movement according to a scale (0= no movement 1= slight extremity tensing, 2= extremity withdrawal, 3=generalized movement.
Intravenous cannulation without any laryngospasm or movement will be considered successful.
Measured: The outcome will be assessed at the time of intravenous cannulation attempt.
Secondary outcomes (2)
To assess level of preoperative sedation
The level of sedation will be assessed with Ramsay Sedation Scale. This scale includes the following categories: 1, anxious, restless, or agitated; 2, cooperative; 3, responds to commands only; and 4-6, different levels of unconsciousness, where 6 indicates no response to a light glabellar tap or loud auditory stimulus. Higher scores denote higher levels of sedation. Assessment will be started from acceptance of the patient to the preoperative holding area (baseline) to the time when anesthesia preparation will occur. The children will be evaluated 3 times, at baseline, post-premedication 40th minute, and during anesthesia preparation in the operating room.
Measured: Assesment of children will be started from acceptance of patient to preoperative holding area to the time of anesthesia preparation.
To assess level of preoperative anxiety
Anxiety will be measured at the time of arrival in the preoperative holding area (baseline) and during anesthesia preparation in the operating room. The level of anxiety will be assessed using the validated Turkish version of the modified Yale Preoperative Anxiety Scale (mYPAS), containing 27 items in five categories (activity, emotional, expressivity, state of arousal, vocalization, and use of parents), representing five domains ofanxiety.The mYPAS scale ranges from 0 to 100 points, with higher scores signifying higher levels of anxiety. Assessment will be started from acceptance of the patient to the preoperative holding area (baseline) to the time when anesthesia preparation will occur. The children will be evaluated 3 times, at baseline, post-premedication 40th minute, and during anesthesia preparation in the operating room.
Measured: Assesment of children will be started from acceptance of patient to preoperative holding area to the time of anesthesia preparation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start2 Dec 2021
- Primary completion4 Feb 2022
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafet Yarimoglu, MD, Principal investigator, Karaman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139212
- Sponsor's protocol ID
- 08-2021/02
- Status last verified
- Nov 2021
- First submitted
- 17 Nov 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Optimum Time for Intravenous Cannulation After General Anesthesia Induction With Sevoflurane and Nitrous Oxide in Children Undergoing Elective Surgery With Dexmedetomidine Premedication
- ClinicalTrials.gov ID
- NCT05139212
- Acronym / sponsor ID
- 08-2021/02
- Conditions
- Cannulation, Sevoflurane Induction, Dexmedetomidine
- Keywords
- Induction of anesthesia, Sevoflurane, Nitrous oxide, Dexmedetomidine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 1 Dec 2021 (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.
Inhalational induction with sevoflurane, nitrous oxide, and oxygen is accepted as a safe technique to avoid any movement during intravenous cannulation in children. In addition, intranasal dexmedetomidine could be used for premedication to reduce preoperative anxiety in preschool children. Early attempts to place, an intravenous line may result in movement and respiratory complications like coughing or laryngospasm. On the other hand delay in cannulation may prevent effective management of bradycardia and hypotension. There are a number of studies examining the optimum time for cannulation after sevoflurane induction. However, it is not known whether the addition of dexmedetomidine premedication affects the time for intravenous cannulation following induction with sevoflurane and nitrous oxide.
Detailed description
All the children will be premedicated with intranasal 2mcg/kg dexmedetomidine 40 minutes before the surgery. Ramsay sedation scale and Turkish version of modified Yale Preoperative Anxiety Scale (mYPAS) will be measured at the time of arrival in the daycare unit and during anesthesia preparation in the operating room.
The same anesthesia machine 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 liter/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, the fresh gas flow will be reduced to 3 liter/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 24-gauge stainless steel guide cannula.
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, and the procedure will be considered successful in the absence of any reaction.
The time for the subsequent patient's intravenous cannulation will be adjusted accordingly using Dixon's up-down sequential method (starting at 4 min with 15 s as the step size). The time for cannulation will be increased by 15 s if the time will be inadequate in the previous patient, and conversely, the time for cannulation will be decreased by 15 s if the time will be adequate in the previous patient.
The aim of this study will be to determine the optimum time for intravenous cannulation after the induction of anesthesia with sevoflurane, oxygen, and nitrous oxide in children with intranasal dexmedetomidine premedication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 2-6 years, American Society of Anesthesiologists physical status 1 scheduled for elective procedures undergoing inhalational induction after dexmedetomidine premedication without intravenous access will be enrolled in the study.
Key inclusion criteria (1 listed)
- Children with ASA physical status I and scheduled for an elective procedure under general anesthesia without prior intravenous cannulation will be selected
Key exclusion criteria (6 listed)
- 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 who are being treated with sedative or anticonvulsive agents.
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 |
|---|---|---|
| Optimum time for intravenous cannulation in children premedicated with dexmedetomidineThe optimum time for intravenous cannulation after the induction of anesthesia with sevoflurane, oxygen, and nitrous oxide in children with intranasal dexmedetomidine premedication will be searched in children undergoing elective surgery. | Procedure or surgery | – |
Primary outcome
Determination of optimum time for intravenous cannulation after induction with sevoflurane and nitrous oxide in children premedicated with dexmedetomidine
Time frame: The outcome will be assessed at the time of intravenous cannulation attempt.
At the time of intravenous canulation attempt, an independent observer who will be blinded about predetermined canülation time, rated the movement according to a scale (0= no movement 1= slight extremity tensing, 2= extremity withdrawal, 3=generalized movement. Intravenous cannulation without any laryngospasm or movement will be considered successful.
2 secondary outcomes
To assess level of preoperative sedation
Time frame: Assesment of children will be started from acceptance of patient to preoperative holding area to the time of anesthesia preparation.
To assess level of preoperative anxiety
Time frame: Assesment of children will be started from acceptance of patient to preoperative holding area to the time of anesthesia preparation.
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 7 Feb 2022.
Related trials for Cannulation
Not yet recruitingObservational study
Diagnosis of ECMO Cannula Infection: Prospective Comparison of Sampling Methods
ECMO Cannula Infection, Extracorporeal Membrane Oxygenation Complication
Enrolling by invitation
TruVascular Access - Ultrasound-Guided Vascular Access Study
Peripheral Venous Catheterization, Difficult Intravenous Access
Recruiting
Study of 3D Ultrasound for Support of Hemodialysis Cannulation
Dialysis
Recruiting
Robotic RVO Trial: Robot-assisted Retinal Vein Cannulation in Patients With Retinal Vein Occlusions
Retinal Vein Occlusion (RVO)
Active, not recruiting
Handheld US Device to Verify Vascular Cannulation
Surgery
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.
Rafet Yarimoglu, MD principal investigator
Karaman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cannulation and Sevoflurane Induction, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 6 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 7 Feb 2022. 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 Turkey (Türkiye). 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?
Determination of optimum time for intravenous cannulation after induction with sevoflurane and nitrous oxide in children premedicated with dexmedetomidine (time frame: The outcome will be assessed at the time of intravenous cannulation attempt.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2022.