Comparing Inhalation and Total Intravenous Anesthesia Methods

NCT ID: NCT06467279

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2023-12-15

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.

Conditions

Children; Hernia, Inguinal

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Target Controlled İnfusion

Intervention Type: 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.

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.

Inhalation anesthetic

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DEVICE

Inhalation anesthetic

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

Intervention Type: DRUG

Other Intervention Names

TCI; Sevoflurane

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Özlem ÖZ GERGİN

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Özlem OZ GERGİN, MD

Role: STUDY_DIRECTOR

TC Erciyes University

Locations

Özlem OZ GERGİN

Kayseri, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TDK-2022-11979

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2022/200

Identifier Type: -

Identifier Source: org_study_id