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Comparing Inhalation and Total Intravenous Anesthesia Methods (TIVA-IHA)

T

TC Erciyes University

Status

Completed

Conditions

Hernia, Inguinal
Children

Treatments

Drug: Inhalation anesthetic
Device: Target Controlled İnfusion

Study type

Observational

Funder types

Other

Identifiers

NCT06467279
2022/200
TDK-2022-11979 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

3 to 12 years old

Volunteers

No Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

TOTAL INTRAVENOUS ANESTHESIA GROUP
Description:
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.
Treatment:
Device: Target Controlled İnfusion
The Patient Group Receiving Inhalation Anesthesia
Description:
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.
Treatment:
Drug: Inhalation anesthetic

Trial contacts and locations

1

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Central trial contact

Özlem OZ Gergin, MD

Data sourced from clinicaltrials.gov

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