Pediatric PatientsNCT06265610
A Comparison Of The Effect Of Target-Controlled Infusion Anesthesia And Inhalation Anesthesia
An observational study of Pediatric Patients and Cardiology, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
A total of 70 patients who underwent angiographic examination, ASD closure, VSD closure, PDA closure and aortic balloon dilatation were included in this study. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Patients, Cardiology
- What is being tested?
- TIVA/TCI
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 1 Oct 2023
- 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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: children ages 3 to 18 with heart disease
Who may be able to join
- Children weighing over 10 kg and between the ages of 3-18 who will undergo angiography
- Patients who are not allergic to the drugs used
Who cannot join
- ASA Ⅳ patients
- Patients with Diabetes Mellitus
- Patients with severe lung disease
- Patients with psychiatric disorders
- Patients with opioid addiction -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Of The Effect Of Target-Controlled Infusion Anesthesia And Inhalation Anesthesia On Patient Outcomes In Pediatric Patients Undergoing Endovascular Intervention
A total of 70 patients who underwent angiographic examination, ASD closure, VSD closure, PDA closure and aortic balloon dilatation were included in this study.
Read the detailed description
A total of 70 patients who underwent angiographic examination, ASD closure, VSD closure, PDA closure and aortic balloon dilatation were included in this study. Patients underwent standard electrocardiography (ECG) monitoring with heart rate (HR), noninvasive blood pressure (NIKB), peripheral oxygen saturation (SpO2) and Bispectral index (BIS). Baseline NIKB, SpO2 and HR were recorded before the procedure, intraoperatively and in the postoperative recovery unit. In the postoperative recovery unit, the patient's recovery time was also evaluated and recorded with the Modified Aldrete Recovery Score.
- Conditions
- Pediatric Patients, Cardiology
- Being tested
- TIVA/TCI
- Keywords
- Sevoflurane,, Propofol, Target Controlled Infusion,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIVA/TCIProcedure or surgery
Also called Inhalatıon
: The aim of this study was to evaluate the effects of total intravenous anesthesia with target-controlled infusion (TCI/TIVA) on intraoperative hemodynamic parameters and postoperative awakening criteria in pediatric endovascular intervention patients
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Total intravenous anesthesia with target-controlled infusion (TCI/TIVA) was applied as an anesthesia method to be applied to patients during cardiology angiography procedures. Receives: Procedure: TIVA/TCI | |
| Group 2 | In the anesthesia method to be applied to patients during cardiology angiography procedures, inhalation anesthesia was applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative period
During cardiology angiography procedures, patients' heart rate,measurements will be evaluated.
Measured: an average of 2 hours
postoperative period
During cardiology angiography procedures, patients' eye opening time will be evaluated.
Measured: an average of 2 hours
hemodynamic parameters
During cardiology angiography procedures, patienheart ts' mean arterial pressure (MAP),measurements will be evaluated.
Measured: an average of 2 hours
Secondary outcomes (1)
Modified Aldrete Recovery Score
Modified Aldrete Recovery Score will be evaluated in the postoperative period
Measured: during the processing period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Mar 2022
- Primary completion1 Sep 2023
- Study completion1 Oct 2023
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 Pediatric PatientsStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Seçkin Pehlivan, TC Erciyes University
- Investigators
- Sibel Pehlivan, MD, Study director, TC Erciyes UniversityMustafa Cakıllı, Principal investigator, Department of Anaesthesiology and Reanimation, Yozgat City Hospital,Ozlem OZ GERGIN, MD, Principal investigator, Department of Anaesthesiology and Reanimation, Medical Faculty, Erciyes UniversityAli BAYKAN, Prof, Principal investigator, Department of Pedıatrıc Cardiology, Medical Faculty, Erciyes UniversityRecep AKSU, Prof, Principal investigator, Department of Anaesthesiology and Reanimation, Medical Faculty, Erciyes UniversityKaramehmet YILDIZ, prof, Principal investigator, Department of Anaesthesiology and Reanimation, Medical Faculty, Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265610
- Sponsor's protocol ID
- 2022/186
- Status last verified
- Nov 2024
- First submitted
- 12 Jan 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared upon reasonable request to the corresponding author.
Publications
Lerman J, Johr M. Inhalational anesthesia vs total intravenous anesthesia (TIVA) for pediatric anesthesia. Paediatr Anaesth. 2009 May;19(5):521-34. doi: 10.1111/j.1460-9592.2009.02962.x. No abstract available.
PubMed 19453585Lerman J. TIVA, TCI, and pediatrics: where are we and where are we going? Paediatr Anaesth. 2010 Mar;20(3):273-8. doi: 10.1111/j.1460-9592.2009.03238.x. Epub 2010 Jan 19.
PubMed 20102520
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Of The Effect Of Target-Controlled Infusion Anesthesia And Inhalation Anesthesia On Patient Outcomes In Pediatric Patients Undergoing Endovascular Intervention
- ClinicalTrials.gov ID
- NCT06265610
- Acronym / sponsor ID
- 2022/186
- Conditions
- Pediatric Patients, Cardiology
- Keywords
- Sevoflurane,, Propofol, Target Controlled Infusion,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 20 Feb 2024 (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.
A total of 70 patients who underwent angiographic examination, ASD closure, VSD closure, PDA closure and aortic balloon dilatation were included in this study.
Detailed description
A total of 70 patients who underwent angiographic examination, ASD closure, VSD closure, PDA closure and aortic balloon dilatation were included in this study. Patients underwent standard electrocardiography (ECG) monitoring with heart rate (HR), noninvasive blood pressure (NIKB), peripheral oxygen saturation (SpO2) and Bispectral index (BIS). Baseline NIKB, SpO2 and HR were recorded before the procedure, intraoperatively and in the postoperative recovery unit. In the postoperative recovery unit, the patient's recovery time was also evaluated and recorded with the Modified Aldrete Recovery Score.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Procedure: TIVA/TCITotal intravenous anesthesia with target-controlled infusion (TCI/TIVA) was applied as an anesthesia method to be applied to patients during cardiology angiography procedures. |
| Group 2 | – | –In the anesthesia method to be applied to patients during cardiology angiography procedures, inhalation anesthesia was applied. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- children ages 3 to 18 with heart disease
Key inclusion criteria (2 listed)
- Children weighing over 10 kg and between the ages of 3-18 who will undergo angiography
- Patients who are not allergic to the drugs used
Key exclusion criteria (5 listed)
- ASA Ⅳ patients
- Patients with Diabetes Mellitus
- Patients with severe lung disease
- Patients with psychiatric disorders
- Patients with opioid addiction -
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 |
|---|---|---|
| TIVA/TCIAlso: Inhalatıon: The aim of this study was to evaluate the effects of total intravenous anesthesia with target-controlled infusion (TCI/TIVA) on intraoperative hemodynamic parameters and postoperative awakening criteria in pediatric endovascular intervention patients | Procedure or surgery | group 1 |
Primary outcome
intraoperative period
Time frame: an average of 2 hours
During cardiology angiography procedures, patients' heart rate,measurements will be evaluated.
postoperative period
Time frame: an average of 2 hours
During cardiology angiography procedures, patients' eye opening time will be evaluated.
hemodynamic parameters
Time frame: an average of 2 hours
During cardiology angiography procedures, patienheart ts' mean arterial pressure (MAP),measurements will be evaluated.
1 secondary outcome
Modified Aldrete Recovery Score
Time frame: during the processing period
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 19 Nov 2024.
- Results publication: PubMed 19453585Lerman J, Johr M. Inhalational anesthesia vs total intravenous anesthesia (TIVA) for pediatric anesthesia. Paediatr Anaesth. 2009 May;19(5):521-34. doi: 10.1111/j.1460-9592.2009.02962.x. No abstract available.
- Results publication: PubMed 20102520Lerman J. TIVA, TCI, and pediatrics: where are we and where are we going? Paediatr Anaesth. 2010 Mar;20(3):273-8. doi: 10.1111/j.1460-9592.2009.03238.x. Epub 2010 Jan 19.
- Individual participant dataSharing planned: Yes. Data can be shared upon reasonable request to the corresponding author.
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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.
Sibel Pehlivan, MD study director
TC Erciyes University
Mustafa Cakıllı principal investigator
Department of Anaesthesiology and Reanimation, Yozgat City Hospital,
Ozlem OZ GERGIN, MD principal investigator
Department of Anaesthesiology and Reanimation, Medical Faculty, Erciyes University
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 Pediatric Patients and Cardiology, run by TC Erciyes University 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 2 inclusion and 5 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 19 Nov 2024. 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?
intraoperative period (time frame: an average of 2 hours). The study lists 3 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 NCT06265610, 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 19 Nov 2024.