Skip to main content
OpenTrials
Completed

NCT Number: NCT06467279

Comparing Inhalation and Total Intravenous Anesthesia Methods

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Children Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Özlem OZ GERGİN

Kayseri, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Target Controlled İnfusion

Device

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.

Other names: TCI

Inhalation anesthetic

Drug

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

Other names: Sevoflurane

Primary outcomes

  1. 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.

Secondary outcomes

  1. blood pressure (mmHg)

    Time frame: after surgery 1 hours

    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.

  2. heart rate (Beats/minute)

    Time frame: after surgery 1 hours

    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.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

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

Acronym: TIVA-IHA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 20, 2024
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.