Laparoscopic SurgeryNCT06571682
Comparison of Target Controlled Infusion Anesthesia and Inhalation Anesthesia in Pediatric Laparoscopic Surgeries
An observational study of Laparoscopic Surgery and Target Controlled Infusion, run by TC Erciyes University.
Trial summary
Comparison of Target Controlled Infusion Anesthesia and Inhalation Anesthesia in Pediatric Laparoscopic Surgeries Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Laparoscopic Surgery, Target Controlled Infusion
- What is being tested?
- Inhalation anesthetic
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2024to 30 Mar 2025
- 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 laparoscopic surgery
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 and above pediatric patients.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of the Effect of Anesthesia Applied by Target Controlled Infusion Method and Inhalation Anesthesia Method on Patient Outcomes in Pediatric Patients Undergoing Laparoscopic Surgery
Comparison of Target Controlled Infusion Anesthesia and Inhalation Anesthesia in Pediatric Laparoscopic Surgeries
Read the detailed description
In pediatric age group patients undergoing laparoscopic surgery, total intravenous anesthesia (TIVA) and inhalation anesthesia methods are used as anesthesia methods in the intraoperative period; It is compared in terms of its effects on blood pressure, pulse, postoperative awakening time and awakening agitation.
- Conditions
- Laparoscopic Surgery, Target Controlled Infusion
- Being tested
- Target Controlled Infusion, Inhalation anesthetic
- Keywords
- Pediatric Laparoscopic Surgery, Target Controlled Infusion, Propofol, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target Controlled InfusionDevice
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 | Patients will undergo anesthesia induction as routine after premedication. Once the target BIS level is reached (40-60) and muscle relaxation is achieved, the airway will be secured with an appropriately sized endotracheal tube or laryngeal mask (LMA).
The effect zone target concentration of propofol will be adjusted to 3 mcg/ml with the HKI device.
Patients will receive controlled ventilation with 50% oxygen/air, and mechanical ventilation parameters will be adjusted so that the end tidal carbon dioxide level (EtCO2) is 35-45 mmHg. Receives: Device: Target Controlled Infusion | |
| Inhalation Anesthesia Group | Patients will undergo anesthesia induction as routine after premedication. The level of sevoflurane, an inhalation gas, will be adjusted so that BIS values are between 40-60. Patients will receive controlled ventilation with 50% oxygen/air, and mechanical ventilation parameters will be adjusted so that the end tidal carbon dioxide level (EtCO2) is 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: Aftet surgery 1 hour
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 surger 1 hour
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 surgey 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start15 Sep 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
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
- NCT06571682
- Sponsor's protocol ID
- 2022/354
- Status last verified
- Aug 2024
- First submitted
- 3 Jun 2024
- Last updated
- 26 Aug 2024
- 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 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Anesthesia Applied by Target Controlled Infusion Method and Inhalation Anesthesia Method on Patient Outcomes in Pediatric Patients Undergoing Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT06571682
- Acronym / sponsor ID
- 2022/354
- Conditions
- Laparoscopic Surgery, Target Controlled Infusion
- Keywords
- Pediatric Laparoscopic Surgery, Target Controlled Infusion, Propofol, Sevoflurane
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 26 Aug 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.
Comparison of Target Controlled Infusion Anesthesia and Inhalation Anesthesia in Pediatric Laparoscopic Surgeries
Detailed description
In pediatric age group patients undergoing laparoscopic surgery, total intravenous anesthesia (TIVA) and inhalation anesthesia methods are used as anesthesia methods in the intraoperative period; It is compared in terms of its effects on blood pressure, pulse, postoperative awakening time and awakening agitation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Intravenous Anesthesia Group | – | Device: Target Controlled InfusionPatients will undergo anesthesia induction as routine after premedication. Once the target BIS level is reached (40-60) and muscle relaxation is achieved, the airway will be secured with an appropriately sized endotracheal tube or laryngeal mask (LMA). The effect zone target concentration of propofol will be adjusted to 3 mcg/ml with the HKI device. Patients will receive controlled ventilation with 50% oxygen/air, and mechanical ventilation parameters will be adjusted so that the end tidal carbon dioxide level (EtCO2) is 35-45 mmHg. |
| Inhalation Anesthesia Group | – | Drug: Inhalation anestheticPatients will undergo anesthesia induction as routine after premedication. The level of sevoflurane, an inhalation gas, will be adjusted so that BIS values are between 40-60. Patients will receive controlled ventilation with 50% oxygen/air, and mechanical ventilation parameters will be adjusted so that the end tidal carbon dioxide level (EtCO2) is 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 laparoscopic surgery
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 and above 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 InfusionAlso: 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 | Inhalation Anesthesia Group |
Primary outcome
Modified Aldrete Scoring System
Time frame: Aftet surgery 1 hour
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 surger 1 hour
Heart rate (beats/minute)
Time frame: After surgey 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Surgery and Target Controlled Infusion, run by TC Erciyes University.
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: status not confirmed, as of the sponsor's last update on 26 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Özlem OZ GERGIN, MD (09005332466396, oozgergin@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Aldrete Scoring System (time frame: Aftet surgery 1 hour). 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 26 Aug 2024.