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

January 31, 2026 updated by: Özlem ÖZ GERGİN, TC Erciyes University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Children aged 3-12 with ASA I-II undergoing inguinal hernia repair.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Target 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.
Other Names:
  • TCI
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.
Drug: Inhalation anesthetic
In the inhalation anesthesia group, maintenance sevoflurane anesthesia will be applied after routine induction.
Other Names:
  • Sevoflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
after surgery 1 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
after surgery 1 hours
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.
after surgery 1 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Investigators

  • Study Director: Özlem OZ GERGİN, MD, TC Erciyes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Actual)

December 15, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

June 14, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 31, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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