ChildrenTIVA-IHANCT06467279
Comparing Inhalation and Total Intravenous Anesthesia Methods
An observational study of Children and Hernia, Inguinal, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study compares the effects of anesthesia using target-controlled infusion (TCI) and inhalation methods on pediatric patients undergoing inguinal hernia repair. The main outcomes include intraoperative hemodynamic stability and postoperative recovery characteristics. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Children, Hernia, Inguinal
- What is being tested?
- Inhalation anesthetic
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2022to 15 Dec 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 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 3-12 with ASA I-II undergoing inguinal hernia repair.
Who may be able to join
- Children aged 3-12 years
- Patients weighing over 10 kilograms
- Patients who will undergo inguinal hernia surgery
- ASA (American Society of Anesthesiologists) classification I and II pediatric patients.
Who cannot join
- Absence of systemic illness.
- ASA (American Society of Anesthesiologists) classification III pediatric patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Patient Outcomes Between Anesthesia Administered Via Target-controlled Infusion Method and Inhalation Anesthesia Method in Pediatric Patients Undergoing Inguinal Hernia Repair
This study compares the effects of anesthesia using target-controlled infusion (TCI) and inhalation methods on pediatric patients undergoing inguinal hernia repair. The main outcomes include intraoperative hemodynamic stability and postoperative recovery characteristics. Sixty children were randomized to receive either total intravenous anesthesia (TIVA) via the Eleveld model or inhalation anesthesia with sevoflurane. The study aims to evaluate which method is safer and more effective in pediatric surgical anesthesia.
Read the detailed description
This prospective, randomized, controlled study was conducted to evaluate the effects of two anesthesia techniques-target-controlled infusion using total intravenous anesthesia and inhalation anesthesia-on intraoperative hemodynamic stability and postoperative recovery quality in pediatric patients undergoing elective inguinal hernia repair. A total of 60 patients aged 3 to 12 years were randomly assigned to either the TIVA group, which received propofol via TCI using the Eleveld pharmacokinetic model, or the inhalation group, which received sevoflurane-based anesthesia. Standard monitoring included bispectral index (BIS), oxygen saturation (SpO₂), heart rate, and blood pressure measurements. Recovery was assessed using modified Aldrete scoring. A consistent anesthesia depth (BIS 40-60) and standardized ventilatory strategies were maintained for all participants. The aim of this study is to provide comparative data on the safety, efficacy, and recovery profiles of both anesthesia methods in the context of pediatric surgical care.
- Conditions
- Children, Hernia, Inguinal
- Being tested
- Target Controlled İnfusion, Inhalation anesthetic
- Keywords
- BIS, TIVA, İNFUSİON, İNGUİNAL HERNİA
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target Controlled İnfusionDevice
Also called TCI
TCI (Target-Controlled Infusion) is a method used to maintain the dose and rate of anesthesia drugs within a target concentration range set by the anesthetist. This system delivers drugs intravenously to the patient using a computer-controlled pump. The anesthetist adjusts the drug concentration to achieve the desired depth of anesthesia. This method provides more precise control over anesthesia and facilitates maintaining the depth of anesthesia within the desired range.
Inhalation anestheticDrug
Also called Sevoflurane
In the inhalation anesthesia group, maintenance sevoflurane anesthesia will be applied after routine induction.
| Study group | Role | What they receive |
|---|---|---|
| TOTAL INTRAVENOUS ANESTHESIA GROUP | After premedication, anesthesia induction will be performed as per routine. Upon reaching the target Bispectral Index (BIS) level (40-60) and ensuring muscle relaxation, the airway will be secured with an appropriately sized endotracheal tube or laryngeal mask airway (LMA). The target concentration of Propofol in the effect site will be set at 3 mcg/ml using a Target-Controlled Infusion (TCI) device. Controlled ventilation will be conducted with 50% oxygen/air mixture, adjusting mechanical ventilation parameters to maintain End-Tidal Carbon Dioxide (EtCO2) levels between 35-45 mmHg. Receives: Device: Target Controlled İnfusion | |
| The Patient Group Receiving Inhalation Anesthesia | Patients will be induced with the same anesthesia as Group I, and BIS values will be adjusted to be between 40-60 at the routinely used inhalation gas level of sevoflurane. Patients will be given controlled ventilation with 50% Oxygen/air, and mechanical ventilation materials will be adjusted so that the end tidal carbon dioxide level (EtCO2) will be 35-45 mmHg. Receives: Drug: Inhalation anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Aldrete Scoring System
The effects on recovery were monitored within the first hour of the postoperative period using the Modified Aldrete Scoring System (MASS). Totally 0-10 points can be given by MASS. Higher scores predicts better recovery.
Measured: after surgery 1 hours
Secondary outcomes (2)
blood pressure (mmHg)
The blood pressure of the patients will be measured and recorded in mmHg at five-minute intervals from the beginning until the first postoperative hour.
Measured: after surgery 1 hours
heart rate (Beats/minute)
The heart rate of the patients will be measured and recorded in mmHg at five-minute intervals from the beginning until the first postoperative hour.
Measured: after surgery 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start15 Aug 2022
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem ÖZ GERGİN, TC Erciyes University
- Investigators
- Özlem OZ GERGİN, MD, Study director, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467279
- Sponsor's protocol ID
- 2022/200
- Other IDs
- TDK-2022-11979
- Acronym
- TIVA-IHA
- Status last verified
- Jan 2026
- First submitted
- 16 Apr 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patient Outcomes Between Anesthesia Administered Via Target-controlled Infusion Method and Inhalation Anesthesia Method in Pediatric Patients Undergoing Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT06467279
- Acronym / sponsor ID
- TIVA-IHA / 2022/200
- Conditions
- Children, Hernia, Inguinal
- Keywords
- BIS, TIVA, İNFUSİON, İNGUİNAL HERNİA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 20 Jun 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.
This study compares the effects of anesthesia using target-controlled infusion (TCI) and inhalation methods on pediatric patients undergoing inguinal hernia repair. The main outcomes include intraoperative hemodynamic stability and postoperative recovery characteristics. Sixty children were randomized to receive either total intravenous anesthesia (TIVA) via the Eleveld model or inhalation anesthesia with sevoflurane. The study aims to evaluate which method is safer and more effective in pediatric surgical anesthesia.
Detailed description
This prospective, randomized, controlled study was conducted to evaluate the effects of two anesthesia techniques-target-controlled infusion using total intravenous anesthesia and inhalation anesthesia-on intraoperative hemodynamic stability and postoperative recovery quality in pediatric patients undergoing elective inguinal hernia repair. A total of 60 patients aged 3 to 12 years were randomly assigned to either the TIVA group, which received propofol via TCI using the Eleveld pharmacokinetic model, or the inhalation group, which received sevoflurane-based anesthesia. Standard monitoring included bispectral index (BIS), oxygen saturation (SpO₂), heart rate, and blood pressure measurements. Recovery was assessed using modified Aldrete scoring. A consistent anesthesia depth (BIS 40-60) and standardized ventilatory strategies were maintained for all participants. The aim of this study is to provide comparative data on the safety, efficacy, and recovery profiles of both anesthesia methods in the context of pediatric surgical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOTAL INTRAVENOUS ANESTHESIA GROUP | – | Device: Target Controlled İnfusionAfter premedication, anesthesia induction will be performed as per routine. Upon reaching the target Bispectral Index (BIS) level (40-60) and ensuring muscle relaxation, the airway will be secured with an appropriately sized endotracheal tube or laryngeal mask airway (LMA). The target concentration of Propofol in the effect site will be set at 3 mcg/ml using a Target-Controlled Infusion (TCI) device. Controlled ventilation will be conducted with 50% oxygen/air mixture, adjusting mechanical ventilation parameters to maintain End-Tidal Carbon Dioxide (EtCO2) levels between 35-45 mmHg. |
| The Patient Group Receiving Inhalation Anesthesia | – | Drug: Inhalation anestheticPatients will be induced with the same anesthesia as Group I, and BIS values will be adjusted to be between 40-60 at the routinely used inhalation gas level of sevoflurane. Patients will be given controlled ventilation with 50% Oxygen/air, and mechanical ventilation materials will be adjusted so that the end tidal carbon dioxide level (EtCO2) will be 35-45 mmHg. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 3-12 with ASA I-II undergoing inguinal hernia repair.
Key inclusion criteria (4 listed)
- Children aged 3-12 years
- Patients weighing over 10 kilograms
- Patients who will undergo inguinal hernia surgery
- ASA (American Society of Anesthesiologists) classification I and II pediatric patients.
Key exclusion criteria (2 listed)
- Absence of systemic illness.
- ASA (American Society of Anesthesiologists) classification III pediatric patients.
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 |
|---|---|---|
| Target Controlled İnfusionAlso: TCITCI (Target-Controlled Infusion) is a method used to maintain the dose and rate of anesthesia drugs within a target concentration range set by the anesthetist. This system delivers drugs intravenously to the patient using a computer-controlled pump. The anesthetist adjusts the drug concentration to achieve the desired depth of anesthesia. This method provides more precise control over anesthesia and facilitates maintaining the depth of anesthesia within the desired range. | Device | TOTAL INTRAVENOUS ANESTHESIA GROUP |
| Inhalation anestheticAlso: SevofluraneIn the inhalation anesthesia group, maintenance sevoflurane anesthesia will be applied after routine induction. | Drug | The Patient Group Receiving Inhalation Anesthesia |
Primary outcome
Modified Aldrete Scoring System
Time frame: after surgery 1 hours
The effects on recovery were monitored within the first hour of the postoperative period using the Modified Aldrete Scoring System (MASS). Totally 0-10 points can be given by MASS. Higher scores predicts better recovery.
2 secondary outcomes
blood pressure (mmHg)
Time frame: after surgery 1 hours
heart rate (Beats/minute)
Time frame: after surgery 1 hours
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 3 Feb 2026.
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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.
Özlem OZ GERGİN, MD study director
TC 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 Children and Hernia, Inguinal, 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 4 inclusion and 2 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 3 Feb 2026. 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?
Modified Aldrete Scoring System (time frame: after surgery 1 hours). 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 3 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.