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Comparing Inhalation and Total Intravenous Anesthesia Methods

Comparison of Patient Outcomes Between Anesthesia Administered Via Target-controlled Infusion Method and Inhalation Anesthesia Method in Pediatric Patients Undergoing Inguinal Hernia Repair

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06467279
Acronym
TIVA-IHA
Enrollment
60
Registered
2024-06-20
Start date
2022-08-15
Completion date
2023-12-15
Last updated
2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Hernia, Inguinal

Keywords

BIS, TIVA, İNFUSİON, İNGUİNAL HERNİA

Brief 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. 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.

Interventions

DEVICETarget Controlled İnfusion

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.

In the inhalation anesthesia group, maintenance sevoflurane anesthesia will be applied after routine induction.

Sponsors

TC Erciyes University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Absence of systemic illness. * ASA (American Society of Anesthesiologists) classification III pediatric patients.

Design outcomes

Primary

MeasureTime frameDescription
Modified Aldrete Scoring Systemafter surgery 1 hoursThe 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.

Secondary

MeasureTime frameDescription
blood pressure (mmHg)after surgery 1 hoursThe blood pressure of the patients will be measured and recorded in mmHg at five-minute intervals from the beginning until the first postoperative hour.
heart rate (Beats/minute)after surgery 1 hoursThe heart rate of the patients will be measured and recorded in mmHg at five-minute intervals from the beginning until the first postoperative hour.

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTORÖzlem OZ GERGİN, MD

TC Erciyes University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026